Manufacturing Engineer – Biomedical Devices – Integer Holdings
Integer Holdings Corporation is one of the largest medical device contract manufacturers in the world, producing advanced components and complete devices for cardiac rhythm management, vascular access, and surgical applications. Our Clarence, NY facility is seeking a Manufacturing Engineer – Biomedical Devices to support high-volume production of life-critical implantable and disposable medical devices.
Responsibilities
- Support manufacturing process development and optimization for implantable medical device components
- Develop and document process instructions, control plans, and validation protocols (IQ/OQ/PQ)
- Implement lean manufacturing and Six Sigma tools to improve process efficiency and reduce defects
- Investigate manufacturing nonconformances and drive root cause analysis and corrective action
- Collaborate with design engineering on design-for-manufacturability reviews and design transfers
- Support supplier development activities including capacity planning and incoming quality audits
Requirements
- BS in Biomedical Engineering, Manufacturing Engineering, or Mechanical Engineering
- 0-2 years of experience in medical device or regulated manufacturing environment
- Familiarity with ISO 13485, FDA 21 CFR Part 820, and GMP requirements
- Knowledge of statistical process control (SPC), Lean, or Six Sigma tools
- Detail-oriented with strong documentation discipline and ability to work on a manufacturing floor
Benefits
- Competitive compensation with annual performance review
- Comprehensive medical, dental, and vision benefits
- 401(k) retirement plan with company match
- Paid time off and 10 paid holidays annually
- Exposure to advanced medical device manufacturing technologies and a clear career growth path