Sr Software Quality Engineer – Medical Device
Listed on 2026-03-08
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Software Development
Software Engineer, Software Testing, Senior Developer, Software Architect
Title:
Sr Software Quality Engineer – Medical Device
Location:
Boston, Massachusetts (Fully Onsite)
Type: W2 Contract
Duration: 6+ months
Note: "This is not an IT Software Quality Engineer role."
Please review the complete job description carefully before applying. We are specifically looking for a Medical Device Software Quality Engineer with strong experience in Software FMEA, Verification & Validation (V&V), Risk Management, and solid knowledge of IEC 62304 compliance.
Kindly apply only if your experience aligns with these requirements.
We are looking for an experienced Senior Software Quality Engineer to join a cross-functional medical device team in Boston. This role focuses on ensuring software quality compliance throughout the product lifecycle.
Key Responsibilities:- Develop and maintain software quality documentation
- Review software lifecycle activities (requirements, design, development, integration, V&V)
- Lead Risk Management planning & reporting
- Ensure compliance with IEC 62304
- Support software traceability, verification & validation
- Drive process improvements and quality program implementation
- Strong experience in Software FMEA
- Solid knowledge of IEC 62304
- Experience in a regulated medical device environment
- Ability to work independently and mentor junior team members
- 4+ years of relevant experience (or 2+ years with advanced degree)
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