Design Quality Engineer, Software Medical Device

About the role

This is a hands-on role for someone who understands design controls, software lifecycle documentation, risk management, and regulated product development — and who wants to help shape the quality system rather than simply maintain one. This is an intersection role: it requires both medical-device design-controls/quality experience and hands-on software / SaMD lifecycle experience — not one or the other.

Requirements

• 4+ years in medical-device design quality, design assurance, or quality engineering for regulated software (design controls + software lifecycle).
• 2+ years hands-on with SaMD, SiMD, or medical-device software (including digital health / diagnostics software).
• Hands-on experience with design controls, risk management, software validation, traceability, and quality-system documentation.
• Working knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QMSR / 21 CFR Part 820, and 21 CFR Part 11.
• Comfort working directly with software teams using tools such as Jira, GitHub, Confluence, and eQMS systems.

Responsibilities

• Own and improve SaMD design-control deliverables, including user needs, design inputs/outputs, traceability, design reviews, verification/validation evidence, and DHF readiness.
• Partner with software, data science, clinical, and regulatory teams to apply IEC 62304, ISO 14971, ISO 13485:2016, FDA QMSR / 21 CFR Part 820, and applicable software quality practices.
• Support AI/ML model lifecycle quality practices, including documentation, risk controls, change control, validation evidence, and total-product-lifecycle thinking.
• Help define pragmatic QMS processes for a fast-moving regulated startup, including software development, non-product software validation / CSA, supplier controls, CAPA, and audit readiness.
• Contribute to cybersecurity, usability/HFE, post-market, complaint, and quality-metrics activities in partnership with subject-matter experts.

Benefits

• The freedom and trust to define your role as we design, build, and ship our products
• Competitive salary and stock option plan
• Flexible paid time off (vacation, sick leave, and public holidays)
• Flexible schedules
• Company health care plan
• Medical, dental, and vision insurance
• Short and long term disability insurance
• Life insurance policy
• 401k
• Commuter benefits for parking, public transit, carshares, etc.
• Opportunities for continuing education