Senior Engineer II, Quality Design Assurance
Integra LifeSciences · Facility, OH
QualityFull-time$82k–$113kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Integra LifeSciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.