Software Design Quality Engineer

Mondo

Danvers, Massachusetts

Apply

JOB DETAILS

SKILLS

Agile Programming Methodologies, Algorithms, Artificial Intelligence (AI), Atlassian JIRA, Bridge Building, Capital Equipment, Cardiovascular, Civil Engineering, Code of Federal Regulations, Communication Skills, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, DevOps, Documentation, Hazard Analysis, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Internet Security, Maintain Compliance, Medical Equipment, Medical Organizations, Quality Engineering, Quality Management, Regulations, Risk, Risk Analysis, Risk Management, Safety Compliance, Security Analysis, Software Administration, Software Design, Software Development, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), Technical/Engineering Design, Test Plan/Schedule, Validation Documentation

LOCATION

Danvers, Massachusetts

POSTED

24 days ago

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

About the Company

Mondo

Resume Resources

Free Resume Templates Free Resume Builder