Senior Design Assurance Engineer

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.

The Senior Design Assurance Engineer utilizes risk management and quality planning activities to lead quality engineering efforts for new product development from concept through design transfer and commercialization and continuously analyzes Quality Management Systems effectiveness for related processes. They champion departmental and/or cross-functional engineering initiatives, including early commercialization sustaining, and acts as an effective leader in supporting Quality responsibilities, decisions and practices for the development and lifecycle of medical devices.

Responsibilities

• Core Team member of medical device development programs ensuring compliance to internal and external requirements.
• Responsible and accountable for design controls (including testing of design controls), risk management, and test method development/validation deliverables on cross-functional development teams.
• Responsible for strategic quality planning for new product development programs, including PMS.
• Partners with R&D to ensure robust design controls are established at the proper design level to meet or exceed internal and external requirements and enable successful design transfer.
• Partners with QE to ensure process risks are appropriately estimated and process controls are sufficient and acceptable for manufacturing/sustaining environment.
• Cross-functional leader for completion and maintenance of Risk Management Files.
• Partners with Regulatory to summarize or generate information to be supplied to Regulatory Agencies.
• Utilizes problem solving methodologies to lead failure investigations and ensure root causes are identified and proper controls are established.
• Responsible and accountable for comprehensive and robust change impact assessments for DHF changes during development and following commercialization
• Coaches and mentors product development teams on Design Control and Risk Management best-practices.
• Drives consistent best practices among team members through collaboration and QMS improvements
• Responsible for impact assessment and integration of Quality System changes into project execution.
• Serves as Product Development and device DHF subject matter expert (SME) for internal and external audits.
• Surfaces and/or escalates Quality issues and compliance gaps to appropriate function and organization level.

Minimum Qualifications

• BS or advanced degree in engineering or related discipline
• 5+ years overall medical device experience
• 5+ years experience in Design Assurance, Quality Engineering, or Sustaining Engineering, or related function
• Expert knowledge of Design Control and Risk Management requirements and best practices
• Critical and creative thinking ability to conceive and defend risk-based decisions using engineering and scientific rationale.
• Proven resourcefulness, able to identify, gather, and summarize information independently
• Proficient with Quality Systems as outlined in CFR820/ ISO13485 and knowledgeable of requirements
• Experience in leading investigations and developing effective corrective actions that utilize a risk-based approach
• Demonstrated technical expertise and leadership in Quality principles
• Strong ability to communicate (written and verbally) within and across disciplines and organizational structures.
• Inclined to accept and consider new information in relation to prior conclusions.
• Innate desire to problem solve, natural contributor, benefits from “hands-on” experience and learning
• Practical knowledge of applied statistics, including statistical analysis tools (e.g. Minitab) and common analysis techniques for medical device applications
• High attention to detail, organization and accuracy
• Ability to travel up to 15%

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

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.