Design Assurance Engineer 2

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 Design Assurance Engineer 2 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 for the development and lifecycle of medical devices.

Responsibilities

• Core Team member of medical device development project teams to ensure compliance to Design Controls requirements.
• Responsible for quality activities and deliverables on the cross-functional development team.
• Responsible for strategic quality planning activities on the project, including PMS planning.
• Partners with R&D to ensure proper controls are established at the right level to meet or exceed internal and external requirements.
• Partners with QE to ensure process risks are appropriately estimated and process controls are sufficient
• Cross-functional leader for completion of Risk Management deliverables.
• Partners with Regulatory development project team members to summarize or generate information to be supplied to Regulatory Agencies
• Utilizes problem solving methodologies to lead failure investigation activities to ensure root cause is identified and proper controls are established.
• Leads design verification, design validation, usability and test method validation activities for new product development to meet or exceed internal and external requirements.
• Responsible for comprehensive and robust change impact assessments for engineering changes
• Coaches and mentors product development team on Design Control and Risk Management activities.
• Drives consistent quality engineering practices among DA team members through collaboration and QMS improvements
• Responsible for impact assessment and integration of Quality System changes into project execution.
• Ensures quality system compliance during development and primary development team contact for audits.
• Surfaces Quality System issues/gaps to appropriate organization level.

Minimum Qualifications

• BS or advanced degree in engineering or related discipline
• 2+ years overall medical device experience
• 2+ years experience in quality assurance or engineering function
• Expert knowledge of Design Control and Risk Management
• Knowledge of Problem Solving methodologies and approaches
• Experience with Quality Systems as outlined in CFR820/ ISO13485
• Experience with leading CAPA investigations and developing effective corrective actions that utilize a risk based approach
• Demonstrated technical expertise and leadership in quality
• Strong ability to communicate (written and verbally) within and across disciplines and organizational structures
• Demonstrated use of Quality tools and methodologies
• Practical knowledge of applied statistics, including statistical analysis tools (Minitab, JMP, etc.)
• High attention to detail, organization and accuracy

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.