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Tier-1 brand and metro location balanced by niche medical-device QA specialization.
High because medical-device regulatory standards and IEC/ISO expertise limit cross-industry portability.
High due to explicit 8+ years and mandatory medical-device standards and tool expertise.
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Support New Product Development and Sustaining projects for software, firmware, and hardware from a Software Design Quality Assurance perspective.
Develop and review Software Design Verification Plans, Protocols, Reports and conduct verification activities accordingly.
Lead risk management activities including creation and review of risk files aligned with ISO 14971, IEC 62304, and serve as SME for software design assurance and quality process implementation.
Bachelor's or Master's degree in relevant engineering field (e.g., Biomedical, Computer Science, Software Development, Electrical).
8+ years experience in Software Quality and/or Software Development in medical device industry with hands-on software design verification or development experience.
Expertise in 21 CFR 820, ISO 13485, IEC 14971, IEC 62304; familiarity with IEC 60601 and other medical device standards.
Must reside in or within commuting distance to Colorado Springs, CO; San Diego, CA; or Plymouth, MN, and have US work authorization without visa sponsorship.
Experienced with software development lifecycle methodologies including Agile and SAFe and defect management tools like Jira or Clearquest.
Skilled in risk management and quality assurance processes for medical devices with strong knowledge of regulatory standards.
Able to lead cross-functional collaboration on code review, software security analysis, and quality process improvements in a medical device context.