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Software Design Quality Engineer , location is
hybrid (3 days) to Danvers MA . The start date is
ASAP for this
full time permanent position.
Job Title: Software Design Quality Engineer II
Location-Type: Hybrid (3 days onsite)
Start Date Is: ASAP
Duration: Permanent
Compensation Range: $100-120k salary, bonus eligible
Benefits: Health, dental, vision, 401k, PTO, parental leave
Job Description:Join a top-tier Class III cardiovascular medical device organization developing life-saving,
next-generation technologies. This role supports software design quality and risk management
across highly regulated, patient-critical products, ensuring compliance and safety throughout the
software development lifecycle.
Day-to-Day Responsibilities:- Own and drive software risk management activities (hazard analysis, SFMEA, risk reports)
- Ensure compliance with design controls and regulatory standards (IEC 62304, ISO 14971, etc.)
- Collaborate with cross-functional teams in Agile/DevOps environments
- Support software development through design reviews, sprint participation, and technical feedback
- Develop and review test protocols, reports, and validation documentation
- Contribute to cybersecurity risk assessments and product security activities
- Support CAPA activities and quality system improvements
- Assist with audits and maintain QMS documentation (SOPs, reports, etc.)
Requirements:Must-Haves:- 2 years of experience in medical device industry
- Hands-on experience with risk management (ISO 14971, hazard analysis, SFMEA)
- Experience with software design controls and regulated SDLC (IEC 62304)
- Background in Software as a Medical Device (SaMD) or Software in a Medical Device (SiMD)
- Strong understanding of quality systems (21 CFR Part 820, ISO 13485)
- Experience working in cross-functional engineering environments
- Strong communication skills with ability to bridge engineering and quality
Nice-to-Haves:- Experience with AI/ML or algorithm development
- Exposure to emerging standards (e.g., ISO 34971)
- Cybersecurity experience in regulated environments
- Experience with tools like JIRA, Confluence, or JAMA
- Background in capital equipment or broader system-level engineering