Senior Engineer I, Quality Design Assurance

Senior Engineer II in Quality Design Assurance at Integra LifeSciences supports medical device development within the CSS Quality organization. The role focuses on design quality, risk management, and new product introduction while collaborating across R&D, regulatory, and manufacturing teams.

Responsibilities

• Lead design and development of medical devices with R&D and external partners, including software and electrical architectures
• Lead risk analysis activities including FMEAs and SHAs; apply risk management and mitigation tools
• Develop test plans using statistical methods; evaluate test data and establish acceptance criteria
• Support manufacturing transfer activities and conduct root cause investigations for nonconforming materials
• Fulfill design control requirements including DHF documentation, verification/validation protocols, and FDA/ISO compliance

Requirements

• Bachelor's degree in engineering (Electrical/Electronic, Mechanical, Systems, or Chemical)
• 5+ years medical device or regulated industry experience with ISO 14971, EU MDR, and FDA QSR knowledge
• 5+ years Quality Assurance experience in medical device or pharmaceutical product development
• Proficiency in DFSS, Lean process improvement, and problem-solving methodologies
• Strong statistical analysis skills and working knowledge of design verification/validation methods
• Expert knowledge of ISO 11607, 10993, and functional requirement cascading
• Proficiency with MS Office Suite and statistical software; ability to work independently

Compensation: $82,000–$113,000 USD salary