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Tier-1 employer and metro location increase competition, but senior, specialized medical-device QA reduces applicant density.
Strong medical-device regulatory and IEC/ISO compliance requirements limit cross-industry transferability.
Strict 8+ years and mandatory medical-device regulatory and verification expertise create high shortlisting rigor.
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Support new product development and sustaining projects focusing on software design quality assurance across software, firmware, and hardware.
Develop, review, and conduct software design verification plans, protocols, and reports; lead risk management activities including risk plans, hazard analysis, FMEAs, and software risk assessments.
Serve as software design assurance SME collaborating on code review, unit tests, security analysis, defect triage, and implement best practices for software quality processes.
Bachelor’s or Master’s degree in engineering (e.g., Biomedical, Computer Science, Software, Electrical).
8+ years of experience in software quality and/or software development in the medical device industry with hands-on experience in software design verification or development.
Expertise in 21 CFR 820, ISO 13485, IEC 14971, IEC 62304; working knowledge of IEC 60601 and medical device standards.
Must reside in or within commuting distance to Colorado Springs, CO; San Diego, CA; or Plymouth, MN; US work authorization required; no visa sponsorship or relocation support.
Experienced in medical device software quality assurance and familiar with relevant regulatory standards and risk management frameworks.
Capable of leading cross-functional software design verification and risk management efforts with measurable accountability.
Comfortable working in an office-based role requiring in-person presence at least 3 days per week in specified US locations.