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Tier-1 brand and metro location raise competition, but niche medical-device QA and seniority narrow the pool.
Medical-device regulatory QA expertise limits transferability across industries, so background fit sensitivity is high.
Explicit 8+ years, medical-device standards expertise, and mandated tools make shortlisting highly stringent.
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Support new product development and sustaining projects focusing on software, firmware, and hardware from a Software Design Quality Assurance perspective.
Develop, review, and conduct software design verification plans, protocols, and reports; lead non-product software assessments and qualification efforts.
Lead creation and review of risk management files and ensure effective risk management using feedback from various sources; serve as SME for software design assurance and lead best practices implementation.
B.S./M.S. in relevant engineering field (e.g. Biomedical, Computer Science, Software Development, 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 other relevant 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 benefits provided.
Experienced in software quality assurance and validation within medical device product development and maintenance environments.
Proficient with software development lifecycle methodologies including Agile and SAFe, and tools like Jira/Clearquest, JAMA/IBM DOORs, JMP/Minitab.
Capable of taking ownership of risk management and software design assurance as an SME, collaborating cross-functionally to implement software quality best practices.