Marion Cappadona
Senior Product Manager
- Role
- Senior Product Manager at Arena by PTC
- Location
- Norfolk, MA, US
- LinkedIn followers
- 500 followers
About Marion Cappadona
30 plus years of medical device engineering, quality system, quality engineering, and regulatory compliance experience. Broad experience from engineering product development, quality engineering, quality system development, ISO/EU implementations/upgrades to latest standards/regulations to quality system software implementations. My areas of expertise include eQMS validations including Arena PLM, Software validation (21 CFR 11), Design Controls (21 CFR 820.30), Risk Management (ISO 14971) and Software development (IEC 62304).
Experience
Senior Product Manager
Jul 2024 — Present · Boston, MA, US
Education
Worcester Polytechnic Institute
BS, Mechanical Engineering, minor in Biomedical Engineering, May 1992, Cum Laude
1988 — 1992
Skills
- Iso 13485
- Medical Device Directive
- Design Control
- Fda
- Testing
- Iso 14971
- Medical Devices
- Quality System
- Gmp
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