Sr. Design Assurance Engineer

Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team! The Sr. 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.

Your role with the company:

• Key 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.
• Assures that proper controls are established to meet or exceed internal and external requirements.
• 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 methods validation activities for new product development to meet or exceed internal and external requirements.
• Coaches and mentors product development team on Design Control activities.
• Drives consistent quality engineering practices among DA team members
• Responsible for impact assessment and integration of Quality System changes into project execution.
• Ensures quality system compliance and primary team contact for audits. Surfaces Quality System issues/gaps to appropriate organization level.

• BS or advanced degree in engineering or related discipline
• 5+ years overall medical device experience
• 5+ 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