Principal Manufacturing Engineer - Injection Molding
Medtronic · North Haven, CT
CMCFull-time$123k–$185kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Principal Manufacturing Engineer role focused on injection molding of bioabsorbable medical device components. Requires expertise in processing sensitive polymers within FDA-regulated cleanroom environments, managing the complete lifecycle from tooling design through final packaging and validation.
What they're looking for
- Bachelor's degree with 7+ years relevant experience, or Master's with 5+ years, or PhD with 3+ years
- 5-7 years injection molding experience in regulated manufacturing environment
- Proven expertise with bioabsorbable polymers such as PLA, PLGA, and PGA
- Strong knowledge of GD&T, PFMEA, SPC, Minitab, and process capability analysis
- Solid understanding of ISO 13485, ISO 14644 cleanroom standards, and FDA 21 CFR Part 820
- Proficiency with CAD software, mold flow analysis, and automated equipment design
What you'll be doing
- Establish and optimize injection molding processes using Scientific Molding and Design of Experiments principles
- Lead Design for Manufacturability reviews and partner with toolmakers on mold construction and modifications
- Conduct root-cause investigations of production defects and field returns to implement corrective actions
- Author and execute validation protocols for molding machines, assemblies, and molds per FDA regulations
- Develop standard operating procedures, custom fixtures, and training materials for production lines
Privacy & handoff
This role links to Medtronic'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.