Software Design Quality Engineer

Join a top-tier Class III cardiovascular medical device organization developing life-saving, next-generation technologies. Day-to-Day Responsibilities:Own and drive software risk management activities (hazard analysis, SFMEA, risk reports).

Apply now: 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