Senior Design Assurance Engineer

• 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.

• 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

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