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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 24th, 2020 12:00AM
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Quality Manager
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Open
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Quality Control
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Ballinasloe, Galway County, Ireland
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Oct 16th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<h3>Job Summary</h3>
<p>The Quality Manager provides technical guidance, structure and leadership for the Quality function at Surmodics Ireland. This position will ensure that the site meets and exceeds business plan through leadership of the Quality function, from product development start-up to full commercial production. In this role the Quality Manager will drive and champion the development, education, and facilitation of quality principles throughout the organization to achieve defined customer requirements.</p>
<h3>Responsibilities</h3>
<h4><strong>General Management </strong></h4>
<ul>
<li>Acts as the champion for customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization and act as Management Representative for the Site.</li>
<li>Provide vision and leadership to the overall Quality function and organisation in order to drive improvements to overall quality and compliance</li>
<li>Recruit, motivate, develop and retain team members needed to support the Quality function.</li>
<li>Assess talent and skills needed to support the business and ensure appropriate skills are available</li>
<li>Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the department’s budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions</li>
<li>Ensure that the Quality Management System meets certification body requirements and that these requirements are appropriately implemented and maintained. Promote the awareness of regulatory and customer requirements throughout organization</li>
<li>Represent the organization to outside regulatory bodies and liaising with outside parties on issues related to Quality</li>
</ul>
<h4><strong>Cross Functional Leadership </strong></h4>
<ul>
<li>Participate as a member of the site management team in the development, leadership and management of the site.</li>
<li>Collaborate with other departments (R&amp;D, Operations and Supply chain, Engineering, Finance and HR) to provide guidance and resources for continuous improvement and timely resolution of issues that may impact product realization</li>
<li>Champion, lead, and support complex projects by leading cross-functional teams, actively collaborating with other department directors and managers</li>
<li>Take a leadership role in developing and implementing new techniques and initiatives and challenge people to try new approaches and to become more efficient.</li>
</ul>
<p><strong>Technical Leadership </strong></p>
<ul>
<li>Support and drive data collection and analysis/trending for ongoing monitoring and process/product improvements</li>
<li>Ensure resource alignment and prioritization of resources to support business team and functional objectives</li>
<li>Provide internal and external audit support as necessary</li>
<li>Participate in ongoing problem solving and on corrective action teams</li>
<li>Review and approve CAPA actions in conjunction with Quality Systems</li>
<li>Develop and monitor department budgets.</li>
</ul>
<h4>Minimum Qualifications</h4>
<ul>
<li>Bachelor’s degree in Engineering or Science related field</li>
<li>Minimum 10 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment</li>
<li>Must have experience in people leadership role (at least 3 to 5 years)</li>
<li>Solid quality engineering and systems background</li>
<li>Demonstrated knowledge and application of Design Controls</li>
<li>Demonstrated knowledge of Quality Assurance</li>
<li>Proven track record in managing and building high performance teams</li>
<li>Exceptional leadership and technical competencies</li>
<li>Excellent communication skills, including the ability to communicate to all levels of an organization</li>
<li>Excellent analytical and problem-solving skills</li>
<li>Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance</li>
<li>Strong leadership skills, including influencing and team development</li>
<li>Thorough knowledge of QSR and ISO quality system requirements<u></u></li>
</ul>
<h4><strong>Core Behavioral Competencies</strong></h4>
<p><strong>Thought Leadership</strong></p>
<p>Business Acumen:&nbsp;&nbsp; Leverages insights on the company’s business drivers, market, and industry to drive effective decisions.</p>
<p>Strategic Mindset:&nbsp; Possesses a broad perspective, a strategic mindset, and an external focus.</p>
<p>Innovation:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Continues the entrepreneurial spirit driving improvement, experimentation, and/or intelligent risk-taking.</p>
<p><strong>People Leadership</strong></p>
<p>Collaboration:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Creates a culture in which employees work together for the good of the company and its customers.</p>
<p>Developing Talent:&nbsp; Identifies, deploys, and develops strong team member.</p>
<p>Courage:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Takes charge and conveys authority, determination, and resolve.</p>
<p><strong>Self-Leadership </strong></p>
<p>Initiative:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Is Motivated by challenges and remains determined in the face of obstacles.</p>
<p>Self-Development:&nbsp; Continuously looks for opportunities to gain insights, apply learnings, and demonstrate new skills.</p>
<p>Adaptability:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Adapts effectively to change with self-confidence, composure, and optimism.</p>
<p><strong>Results Leadership</strong></p>
<p>Driving Execution:&nbsp;&nbsp; Knows how to get things done to satisfy customers and meet business targets.</p>
<p>Leading Change:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Drives change in the organization’s systems, processes, people and culture.</p>
<p>Driving Alignment:&nbsp; Creates a shared understanding of and alignment to the organization’s direction and priorities.</p>
<h4><strong>Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, employee stock purchase plan and stock options.</strong></h4>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.</p>
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Oct 24th, 2020 04:27AM
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Oct 24th, 2020 04:27AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 23rd, 2020 12:00AM
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Quality Manager
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Open
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Quality Control
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Ballinasloe, Galway County, Ireland
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Oct 16th, 2020 12:00AM
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|
<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<h3>Job Summary</h3>
<p>The Quality Manager provides technical guidance, structure and leadership for the Quality function at Surmodics Ireland. This position will ensure that the site meets and exceeds business plan through leadership of the Quality function, from product development start-up to full commercial production. In this role the Quality Manager will drive and champion the development, education, and facilitation of quality principles throughout the organization to achieve defined customer requirements.</p>
<h3>Responsibilities</h3>
<h4><strong>General Management </strong></h4>
<ul>
<li>Acts as the champion for customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization and act as Management Representative for the Site.</li>
<li>Provide vision and leadership to the overall Quality function and organisation in order to drive improvements to overall quality and compliance</li>
<li>Recruit, motivate, develop and retain team members needed to support the Quality function.</li>
<li>Assess talent and skills needed to support the business and ensure appropriate skills are available</li>
<li>Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the department’s budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions</li>
<li>Ensure that the Quality Management System meets certification body requirements and that these requirements are appropriately implemented and maintained. Promote the awareness of regulatory and customer requirements throughout organization</li>
<li>Represent the organization to outside regulatory bodies and liaising with outside parties on issues related to Quality</li>
</ul>
<h4><strong>Cross Functional Leadership </strong></h4>
<ul>
<li>Participate as a member of the site management team in the development, leadership and management of the site.</li>
<li>Collaborate with other departments (R&amp;D, Operations and Supply chain, Engineering, Finance and HR) to provide guidance and resources for continuous improvement and timely resolution of issues that may impact product realization</li>
<li>Champion, lead, and support complex projects by leading cross-functional teams, actively collaborating with other department directors and managers</li>
<li>Take a leadership role in developing and implementing new techniques and initiatives and challenge people to try new approaches and to become more efficient.</li>
</ul>
<p><strong>Technical Leadership </strong></p>
<ul>
<li>Support and drive data collection and analysis/trending for ongoing monitoring and process/product improvements</li>
<li>Ensure resource alignment and prioritization of resources to support business team and functional objectives</li>
<li>Provide internal and external audit support as necessary</li>
<li>Participate in ongoing problem solving and on corrective action teams</li>
<li>Review and approve CAPA actions in conjunction with Quality Systems</li>
<li>Develop and monitor department budgets.</li>
</ul>
<h4>Minimum Qualifications</h4>
<ul>
<li>Bachelor’s degree in Engineering or Science related field</li>
<li>Minimum 10 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment</li>
<li>Must have experience in people leadership role (at least 3 to 5 years)</li>
<li>Solid quality engineering and systems background</li>
<li>Demonstrated knowledge and application of Design Controls</li>
<li>Demonstrated knowledge of Quality Assurance</li>
<li>Proven track record in managing and building high performance teams</li>
<li>Exceptional leadership and technical competencies</li>
<li>Excellent communication skills, including the ability to communicate to all levels of an organization</li>
<li>Excellent analytical and problem-solving skills</li>
<li>Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance</li>
<li>Strong leadership skills, including influencing and team development</li>
<li>Thorough knowledge of QSR and ISO quality system requirements<u></u></li>
</ul>
<h4><strong>Core Behavioral Competencies</strong></h4>
<p><strong>Thought Leadership</strong></p>
<p>Business Acumen:&nbsp;&nbsp; Leverages insights on the company’s business drivers, market, and industry to drive effective decisions.</p>
<p>Strategic Mindset:&nbsp; Possesses a broad perspective, a strategic mindset, and an external focus.</p>
<p>Innovation:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Continues the entrepreneurial spirit driving improvement, experimentation, and/or intelligent risk-taking.</p>
<p><strong>People Leadership</strong></p>
<p>Collaboration:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Creates a culture in which employees work together for the good of the company and its customers.</p>
<p>Developing Talent:&nbsp; Identifies, deploys, and develops strong team member.</p>
<p>Courage:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Takes charge and conveys authority, determination, and resolve.</p>
<p><strong>Self-Leadership </strong></p>
<p>Initiative:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Is Motivated by challenges and remains determined in the face of obstacles.</p>
<p>Self-Development:&nbsp; Continuously looks for opportunities to gain insights, apply learnings, and demonstrate new skills.</p>
<p>Adaptability:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Adapts effectively to change with self-confidence, composure, and optimism.</p>
<p><strong>Results Leadership</strong></p>
<p>Driving Execution:&nbsp;&nbsp; Knows how to get things done to satisfy customers and meet business targets.</p>
<p>Leading Change:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Drives change in the organization’s systems, processes, people and culture.</p>
<p>Driving Alignment:&nbsp; Creates a shared understanding of and alignment to the organization’s direction and priorities.</p>
<h4><strong>Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, employee stock purchase plan and stock options.</strong></h4>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.</p>
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Oct 23rd, 2020 06:55AM
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Oct 23rd, 2020 06:55AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 23rd, 2020 12:00AM
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Global Product Manager
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Open
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WPS Marketing
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Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Oct 14th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Product Manager will support R&amp;D efforts around building out a comprehensive transradial access product platform for treating peripheral vascular disease or performing arterial thrombectomy. This role will focus on upstream marketing responsibilities directly tied to new product development and early commercialization efforts including customer requirements definition, product concept validation, financial analysis, business and portfolio strategy and securing Business Unit commitment through market launch.</p>
<h3><br>Responsibilities</h3>
<h4><br>Market Development:</h4>
<p><br>• Develop expertise in endovascular peripheral vascular procedures to support clinical inputs for medical device development, build credibility and partnerships with physician customers and identify and explore opportunities within the continuum of peripheral vascular care. <br>• Partner closely with key thought leaders to anticipate the future market environment, changes in economic climate, the onset of new competitors, and to predict/drive future needs for customers.<br>• Perform market analysis and identify, understand and communicate key market trends and competitive activity to evaluate market opportunities.<br>• Contribute to development of portfolio strategy based on market dynamics that are consistent with corporate goals.<br>• Support external acquisition/strategic alliance activities with market and end-user data.<br>• Establish and execute market development plans to support product commercialization and drive market share, including customer targeting, clinical data analysis, product and procedure education, and communication tools.</p>
<h4>Product Development:</h4>
<p><br>• Work with R&amp;D team to discover, define and build new product pipeline for next generation products to ensure future growth and innovation.<br>• Provide commercial oversight to ensure short-term and long-term product roadmaps that enable the company to achieve commercial objectives. <br>• Offer input and champion new product platforms, line extensions and other product enhancements.<br>• Plan, support, and analyze quantitative and qualitative market research to identify future customer and product opportunities and needs, to inform tradeoffs, and to ensure commercial success.<br>• Lead and/or assist in leading new product development teams. Responsibilities may include team leadership, project management, timeline management, identify and coordinate development requirements and responsibilities.<br>• Serve as liaison between Marketing, Clinical Specialists, Sales and/or Customers and Product Development teams. Share clinical and field feedback with teams.<br>• Identify and communicate unmet clinical needs that drive product design and function. <br>• Work collaboratively with R&amp;D, Marketing and Executive leadership to gain consensus on product design inputs/needs and future product opportunities.<br>• Responsible for drafting documents to support the development process under the quality management system (i.e. Market Specification documents).<br>• Understanding and effectively managing product performance trade-offs with the project teams.<br>• Ensuring user interface, packaging and labeling meet end-user needs.<br>• Coordinating and supporting physician involvement in providing design inputs and product testing.<br>• Perform industry data analysis by evaluating product sales, pricing and volumes. Leverage internal data sources to identify key customer targets and high-volume users to help facilitate early user feedback and adoption.</p>
<h3>Product Marketing:</h3>
<p><br>• Create market models with supporting assumptions in order to determine key financial metrics and market opportunity.<br>• Knowledgeable and key contributor to downstream marketing activities that are consistent with the portfolio and product strategies.<br>• Lead competitive analysis to identify and understand competitive landscape, differentiation, advantage and performance. Initiate comparative test requests with R&amp;D.<br>• Develop and execute commercialization strategy and product launch plans including branding, financial modeling, pricing, forecasting, inventory requirements, claims matrix development, messaging &amp; positioning, sales training &amp; tools, and promotional strategies.<br>• On-going support of commercial products with development of effective messaging and positioning strategies and the literature and tools to communicate them.<br>• Develop and implement product portfolio strategies including development cadence.</p>
<h3><br>Minimum Qualifications</h3>
<p><br>• Bachelor’s Degree in Marketing, Business Administration, Engineering or related field, MBA preferred<br>• Minimum three (3) years’ experience in product management, minimum five (5) years preferred. <br>• Cardiovascular medical device industry experience and knowledge is required; comfortable and experienced in Cath Lab setting is a must.<br>• Proven track record of effective involvement in product development teams and being influential in cross-functional working environments.<br>• Polished and professional, able to be a strong brand ambassador for the company and interact in a genuine way with customers.<br>• Must have full respect for industry and company compliance policies and dedicated to operating within the regulations and spirit of the guidelines.<br>• Excellent presentation skills; ability to communicate effectively in written and verbal format.<br>• Strategic thinker with ability to link strategy to tactics with faultless execution.<br>• Strong analytical skills and data interpretation. Comfortable making data supported recommendations and building a strong business case/justification through modeling to gain organizational support required.<br>• Excellent IT skills, including all Microsoft packages.<br>• Ability to travel 30-40% (domestic and internationally) with periods of more intense travel based on project requirements.<br><br></p>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Oct 23rd, 2020 06:55AM
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Oct 23rd, 2020 06:55AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 24th, 2020 12:00AM
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Senior Process Development Engineer
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Open
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New Products & Technologies
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Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Oct 14th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p style="text-align: left;">The Senior Process Development Engineer provides project level leadership and execution for new product development projects, taking accountability for all process development and verification / validation activities from design freeze through production transfer. Influences design to ensure manufacturability and develops appropriate process capability.</p>
<h3 style="text-align: left;">Job Responsibilities</h3>
<ul>
<li>Leads all process development and production transfer activities, providing technical leadership from Design Verification through initial finished goods units</li>
<li>Leads process development activities required to achieve COGs targets for specific products</li>
<li>Delivers PVAL results (IQ. OQ. PQ, PPQ).</li>
<li>Develops and completes PFMEA and Master Validation Plan utilizing contemporary statistical techniques</li>
<li>Collaborates with Production planning to transfer new processes to commercial manufacturing</li>
<li>
</li><li>Develops and teaches best practices in process development and provides vison for connectivity with other product development disciplines</li>
<li>Supervise direct reports including reinforcing the open-door policy and ensuring duties, responsibilities, authority and expectations for direct reports are defined and understood</li>
<li>Interview, select, train and evaluate performance of new hires to staff the department with motivated and skilled professionals</li>
<li>Provides input to organization strategic planning</li>
<li>Identifies methods to measure system performance and drive systemic improvements<strong><u>&nbsp;</u></strong></li>
</ul>
<p><strong>Note: </strong>90+% of this job involves direct New Product Development activities</p>
<h3>Qualifications</h3>
<ul>
<li>Bachelor’s Degree preferred</li>
<li>With a degree, four years of relevant experience is required</li>
<li>Without a degree, seven years of relevant experience is required</li>
<li>Demonstrated skill and aptitude in the areas of Process Validation, Risk Analysis, and Design Verification and Validation; both in concept and in current industry best practice</li>
<li>Must possess working knowledge of quality system regulations, strong project management, written and oral communication skills</li>
<li>Ability to identify, plan, lead and execute the process development segment of a product development project.</li>
<li>Understanding of budget and planning process and implementation</li>
<li>Familiarity with various materials and processes, such as extrusion processing, injection molding, machine shop operations, fixtures and tooling, adhesive and thermal bonding and various other processes for catheter fabrication and design required</li>
<li>Strong technical knowledge of materials, processes, and equipment common to the development and manufacturing of disposable medical devices (e.g. PTCA catheters), process conception and development, test methods and metrology, documentation, and a working knowledge of medical device regulations</li>
<li>Ability to effectively provide leadership and vision to technical staff is same dicipline</li>
<li>Ability to provide strategic resource and budgetary planning; to set vision and coordinate actions/output of a group on multiple simultaneous programs in support of an overall organizational strategy.</li>
<li>Travel up to 10%</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Oct 24th, 2020 04:27AM
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Oct 24th, 2020 04:27AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 24th, 2020 12:00AM
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Senior Design Assurance Engineer
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Open
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Quality Regulatory Compliance
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Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Oct 14th, 2020 12:00AM
|
|
<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Senior Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices.</p>
<h3><strong>ESSENTIAL JOB FUNCTIONS:</strong></h3>
<ul>
<li>Key member of medical device development project teams to ensure compliance to Design Controls requirements.</li>
<li>Responsible for quality activities and deliverables on the cross-functional development team.</li>
<li>Responsible for strategic quality planning activities on the project, including PMS planning.</li>
<li>Assures that proper controls are established to meet or exceed internal and external requirements.</li>
<li>Cross-functional leader for completion of Risk Management deliverables.</li>
<li>Partners with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies</li>
<li>Utilizes problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.</li>
<li>Leads design verification, design validation, usability and test methods validation activities for new product development to meet or exceed internal and external requirements.</li>
<li>Coaches and mentors product development team on Design Control activities.</li>
<li>Drives consistent quality engineering practices among DA team members</li>
<li>Responsible for impact assessment and integration of Quality System changes into project execution.</li>
<li>Ensures quality system compliance and primary team contact for audits. Surfaces Quality System issues/gaps to appropriate organization level.&nbsp;</li>
</ul>
<h3><strong>Job Requirements</strong></h3>
<ul>
<li>BS or advanced degree in engineering or related discipline</li>
<li>5+ years overall medical device experience</li>
<li>5+ years experience in quality assurance or engineering function</li>
<li>Expert knowledge of Design Control and Risk Management</li>
<li>Knowledge of Problem Solving methodologies and approaches</li>
<li>Experience with Quality Systems as outlined in CFR820/ ISO13485</li>
<li>Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach</li>
<li>Demonstrated technical expertise and leadership in quality</li>
<li>Strong ability to communicate (written and verbally) within and across disciplines and organizational structures</li>
<li>Demonstrated use of Quality tools and methodologies</li>
<li>Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)</li>
<li>High attention to detail, organization and accuracy</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Oct 24th, 2020 04:27AM
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Oct 24th, 2020 04:27AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 24th, 2020 12:00AM
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Senior Regulatory Affairs Associate
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Open
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Regulatory
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Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Oct 14th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Senior Regulatory Affairs Associate supports activities associated with Surmodics’ compliance to all applicable local, state, federal and international regulations, standards, and directives; supports customer regulatory filings and product stewardship issues; and follows regulatory trends that may affect Surmodics’ or our customers’ ability to conduct business.&nbsp; <br> </p>
<h3>Responsibilities</h3>
<h4><strong>Regulatory Support (70%)</strong></h4>
<ul>
<li>Provides Surmodics’ clients and staff support regarding regulatory aspects of Surmodics products implementation and maintenance of Surmodics products into their production lines</li>
<li>Provides regulatory assistance and responds to regulatory questions asked by clients</li>
<li>Constructs, submits and maintains Device/Drug Master Files on Surmodics products and provides authorization letters for access</li>
<li>Participates in hazard analyses when required</li>
<li>Construct and maintain MSDS’s for Surmodics products</li>
<li>Compiles all materials required in submissions (FDA, TSCA, MCA)</li>
<li>Keeps abreast of all regulatory procedures and changes</li>
<li>Assists in the development of systems to support clinical activities</li>
</ul>
<h4><strong>Regulatory C</strong><strong>ompliance Assessment (30%)</strong></h4>
<ul>
<li>Assesses regulatory requirements with respect to the following government agencies: FDA, USDA, OSHA/MNOSHA, EPA/MPCA, NAFTA. Communicates findings to management and recommends programs/procedures to assure compliance</li>
</ul>
<h3>Minimum Qualifications</h3>
<ul>
<li>B.S. degree in Engineering, Chemistry or related discipline</li>
<li>Minimum 5 years’ experience with at least 2 years’ experience in a medical regulated environment</li>
<li>Knowledge of Regulatory requirements for medical devices and/or pharmaceutical credentials</li>
<li>Comprehensive technical skills/knowledge</li>
<li>Advanced problem-solving skills</li>
<li>Advanced written and verbal communication skills</li>
<li>Computer skills appropriate for work responsibilities</li>
<li>High attention to details</li>
<li>Excellent interpersonal skills</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Oct 24th, 2020 04:27AM
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Oct 24th, 2020 04:27AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 26th, 2020 12:00AM
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Receiving Associate
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Open
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Supply Chain
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Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Oct 14th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Receiving Associate is responsible for receiving, warehousing and distributing all incoming materials, supplies, and equipment for the company. They will also provide back-up support for picking, packaging and shipping chemicals and medical devices to domestic and international locations.</p>
<h3>Responsibilities</h3>
<p>This list of duties and responsibilities is not all-inclusive and may be expanded to include other duties and responsibilities as management may deem necessary from time to time.</p>
<p><strong>Receiving (90%)</strong></p>
<ul>
<li>Receive, log and distribute all packages for the company, i.e. chemicals, lab supplies, raw materials for production, compressed gas tanks and office supplies.</li>
<li>Detailed and accurate receiving of purchase orders in ERP system</li>
<li>Coordinate with Buyer and Accounts Payable to resolve receiving and inventory discrepancies</li>
<li>Maintain accurate inventory segregation, i.e. quarantine, released, inbound, outbound</li>
<li>Perform routine cycle counts and assist in discrepancy resolution</li>
<li>Maintain highly organized receiving and storage areas</li>
<li>Material handling and forklift operations</li>
<li>Maintain documents and records for internal and external audits</li>
</ul>
<p><strong>Shipping (10%)</strong></p>
<ul>
<li>Accurately ship materials internationally and domestically</li>
<li>Follow detailed procedures for shipping product to clients</li>
<li>Use barcode scanning to pick customer orders and pack for shipment</li>
<li>Maintain required training for hazmat shipping via FedEx Ship-Manager, UPS WorldShip and DHL</li>
<li>Charge shipments accurately based on customer or company account</li>
</ul>
<h3>Minimum Qualifications</h3>
<ul>
<li>High School Diploma or equivalent</li>
<li>2 years’ experience in a receiving, warehouse or shipping role</li>
<li>Detail oriented and highly organized</li>
<li>Demonstrated ability to use ERP software, computer and other office equipment, material handling equipment</li>
<li>Experienced in Microsoft Excel and Word</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Oct 26th, 2020 06:15AM
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Oct 26th, 2020 06:15AM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Oct 19th, 2020 12:00AM
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Quality Manager
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Open
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Quality Control
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Ballinasloe, Galway County, Ireland
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Oct 16th, 2020 12:00AM
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<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<h3>Job Summary</h3>
<p>The Quality Manager provides technical guidance, structure and leadership for the Quality function at Surmodics Ireland. This position will ensure that the site meets and exceeds business plan through leadership of the Quality function, from product development start-up to full commercial production. In this role the Quality Manager will drive and champion the development, education, and facilitation of quality principles throughout the organization to achieve defined customer requirements.</p>
<h3>Responsibilities</h3>
<h4><strong>General Management </strong></h4>
<ul>
<li>Acts as the champion for customer quality to all employees and builds a culture of customer awareness and responsiveness at all levels in the organization and act as Management Representative for the Site.</li>
<li>Provide vision and leadership to the overall Quality function and organisation in order to drive improvements to overall quality and compliance</li>
<li>Recruit, motivate, develop and retain team members needed to support the Quality function.</li>
<li>Assess talent and skills needed to support the business and ensure appropriate skills are available</li>
<li>Anticipate future needs of the Quality department, by optimizing the efficiency of the department, management of direct reports, creating and managing the department’s budget, as well as, defining and procuring space, equipment, and computer system requirements for the department functions</li>
<li>Ensure that the Quality Management System meets certification body requirements and that these requirements are appropriately implemented and maintained. Promote the awareness of regulatory and customer requirements throughout organization</li>
<li>Represent the organization to outside regulatory bodies and liaising with outside parties on issues related to Quality</li>
</ul>
<h4><strong>Cross Functional Leadership </strong></h4>
<ul>
<li>Participate as a member of the site management team in the development, leadership and management of the site.</li>
<li>Collaborate with other departments (R&amp;D, Operations and Supply chain, Engineering, Finance and HR) to provide guidance and resources for continuous improvement and timely resolution of issues that may impact product realization</li>
<li>Champion, lead, and support complex projects by leading cross-functional teams, actively collaborating with other department directors and managers</li>
<li>Take a leadership role in developing and implementing new techniques and initiatives and challenge people to try new approaches and to become more efficient.</li>
</ul>
<p><strong>Technical Leadership </strong></p>
<ul>
<li>Support and drive data collection and analysis/trending for ongoing monitoring and process/product improvements</li>
<li>Ensure resource alignment and prioritization of resources to support business team and functional objectives</li>
<li>Provide internal and external audit support as necessary</li>
<li>Participate in ongoing problem solving and on corrective action teams</li>
<li>Review and approve CAPA actions in conjunction with Quality Systems</li>
<li>Develop and monitor department budgets.</li>
</ul>
<h4>Minimum Qualifications</h4>
<ul>
<li>Bachelor’s degree in Engineering or Science related field</li>
<li>Minimum 10 years of quality management experience or equivalent in the medical device industry and/or FDA regulated environment</li>
<li>Must have experience in people leadership role (at least 3 to 5 years)</li>
<li>Solid quality engineering and systems background</li>
<li>Demonstrated knowledge and application of Design Controls</li>
<li>Demonstrated knowledge of Quality Assurance</li>
<li>Proven track record in managing and building high performance teams</li>
<li>Exceptional leadership and technical competencies</li>
<li>Excellent communication skills, including the ability to communicate to all levels of an organization</li>
<li>Excellent analytical and problem-solving skills</li>
<li>Demonstrated ability to collaborate with cross functional teams to ensure business success and ensuring compliance</li>
<li>Strong leadership skills, including influencing and team development</li>
<li>Thorough knowledge of QSR and ISO quality system requirements<u></u></li>
</ul>
<h4><strong>Core Behavioral Competencies</strong></h4>
<p><strong>Thought Leadership</strong></p>
<p>Business Acumen:&nbsp;&nbsp; Leverages insights on the company’s business drivers, market, and industry to drive effective decisions.</p>
<p>Strategic Mindset:&nbsp; Possesses a broad perspective, a strategic mindset, and an external focus.</p>
<p>Innovation:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Continues the entrepreneurial spirit driving improvement, experimentation, and/or intelligent risk-taking.</p>
<p><strong>People Leadership</strong></p>
<p>Collaboration:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Creates a culture in which employees work together for the good of the company and its customers.</p>
<p>Developing Talent:&nbsp; Identifies, deploys, and develops strong team member.</p>
<p>Courage:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Takes charge and conveys authority, determination, and resolve.</p>
<p><strong>Self-Leadership </strong></p>
<p>Initiative:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Is Motivated by challenges and remains determined in the face of obstacles.</p>
<p>Self-Development:&nbsp; Continuously looks for opportunities to gain insights, apply learnings, and demonstrate new skills.</p>
<p>Adaptability:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Adapts effectively to change with self-confidence, composure, and optimism.</p>
<p><strong>Results Leadership</strong></p>
<p>Driving Execution:&nbsp;&nbsp; Knows how to get things done to satisfy customers and meet business targets.</p>
<p>Leading Change:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Drives change in the organization’s systems, processes, people and culture.</p>
<p>Driving Alignment:&nbsp; Creates a shared understanding of and alignment to the organization’s direction and priorities.</p>
<h4><strong>Surmodics offers a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension with employer match, employee stock purchase plan and stock options.</strong></h4>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sexual orientation, gender identity, national origin, disability, civil status or members of traveller communities.</p>
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Oct 19th, 2020 05:24PM
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Oct 19th, 2020 05:24PM
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SurModics
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Health Care
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Health Care Equipment & Services
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nasdaq:srdx
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www.surmodics.com
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boards.greenhouse.io
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Sep 25th, 2020 12:00AM
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Process Development Engineer II
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Open
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Commercial Development
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|
Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
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USA
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Sep 25th, 2020 12:00AM
|
|
<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Process Development Engineer 2 will lead technical aspects (coating related) of client and/or internal projects.&nbsp;</p>
<h3>Responsibilities</h3>
<h4><strong>Provides Technical and Project Leadership (70%)</strong></h4>
<ul>
<li>Executes hands-on work under general direction of senior team members</li>
<li>Leads and works directly with clients and internal project teams on coating projects</li>
<li>Works with TS Engineer on technology transfer process and provides ongoing coating support for projects transferred to the customer or an internal production group</li>
<li>Develops new processes and techniques with some supervision</li>
<li>Plans, executes, and documents technical work</li>
<li>Develops qualification and test protocols and executes experiments</li>
</ul>
<h4><strong>Communication (20%)</strong></h4>
<ul>
<li>Leads technical communication (coating focused) with customers and/or with project teams on internal projects</li>
<li>Maintains thorough and up-to-date laboratory records; completes coating and test reports promptly after completion of work</li>
<li>Routinely authors written reports of experiments, results, conclusions, and recommendations for supervisor and project team(s)</li>
</ul>
<h4><strong>Maintains an efficient and organized laboratory environment (10%)</strong></h4>
<ul>
<li>Maintains laboratory supplies</li>
<li>Maintains laboratory equipment and documents maintenance activities</li>
</ul>
<h4>Minimum Qualifications</h4>
<ul>
<li>Bachelor’s Degree in Engineering</li>
<li>2+ years’ experience in process engineering. Medical device industry preferred</li>
<li>Ability to apply analytical skills and scientific technical principles in problem solving and development</li>
<li>Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs</li>
<li>Strong interpersonal and organizational skills and the ability to work effectively as a team member</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Sep 25th, 2020 04:11PM
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Sep 25th, 2020 04:11PM
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SurModics
|
Health Care
|
Health Care Equipment & Services
|
|
nasdaq:srdx
|
www.surmodics.com
|
boards.greenhouse.io
|
Sep 26th, 2020 12:00AM
|
Process Development Engineer II
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Open
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Commercial Development
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|
Eden Prairie, Minnesota, United States
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Eden Prairie
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MN
|
USA
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Sep 25th, 2020 12:00AM
|
|
<p>Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.</p>
<p>Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.</p>
<p>The Process Development Engineer 2 will lead technical aspects (coating related) of client and/or internal projects.&nbsp;</p>
<h3>Responsibilities</h3>
<h4><strong>Provides Technical and Project Leadership (70%)</strong></h4>
<ul>
<li>Executes hands-on work under general direction of senior team members</li>
<li>Leads and works directly with clients and internal project teams on coating projects</li>
<li>Works with TS Engineer on technology transfer process and provides ongoing coating support for projects transferred to the customer or an internal production group</li>
<li>Develops new processes and techniques with some supervision</li>
<li>Plans, executes, and documents technical work</li>
<li>Develops qualification and test protocols and executes experiments</li>
</ul>
<h4><strong>Communication (20%)</strong></h4>
<ul>
<li>Leads technical communication (coating focused) with customers and/or with project teams on internal projects</li>
<li>Maintains thorough and up-to-date laboratory records; completes coating and test reports promptly after completion of work</li>
<li>Routinely authors written reports of experiments, results, conclusions, and recommendations for supervisor and project team(s)</li>
</ul>
<h4><strong>Maintains an efficient and organized laboratory environment (10%)</strong></h4>
<ul>
<li>Maintains laboratory supplies</li>
<li>Maintains laboratory equipment and documents maintenance activities</li>
</ul>
<h4>Minimum Qualifications</h4>
<ul>
<li>Bachelor’s Degree in Engineering</li>
<li>2+ years’ experience in process engineering. Medical device industry preferred</li>
<li>Ability to apply analytical skills and scientific technical principles in problem solving and development</li>
<li>Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs</li>
<li>Strong interpersonal and organizational skills and the ability to work effectively as a team member</li>
</ul>
<p>Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.</p>
<p>Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.</p>
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Sep 26th, 2020 03:42PM
|
Sep 26th, 2020 03:42PM
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SurModics
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Health Care
|
Health Care Equipment & Services
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