Position Details
About this role
Senior Design Quality Engineer I to support lifecycle quality activities for Abiomed's life cycle processes, including risk management, design controls, and verification/validation.
Key Responsibilities
- Lead design assurance activities and risk assessments
- Manage design verification and validation plans
- Review and approve engineering changes and CAPA
- Apply FDA/ISO regulatory knowledge to quality plans
- Coordinate post-market monitoring and investigations
Technical Overview
Regulatory-driven quality role requiring FDA QSRs, ISO 13485, MDD, with experience in FMEA, BRF+/AOM, and cross-functional collaboration in a MedTech environment.
Ideal Candidate
The ideal candidate is an experienced design quality engineer with 8+ years in medical device quality, strong regulatory knowledge (FDA QSRs, ISO 13485, MDD), and proven leadership in risk management and design verification/validation.
Must-Have Skills
None listed
Required Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Less than 8 years of quality experience, No medical device regulatory experience, Lack of knowledge in design verification/validation, Inability to work in hybrid Danvers, MA
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