Staff SW QA Engineer

Role overview Provide technical leadership in software quality assurance and risk management for regulated medical software. You will shape lifecycle practices and compliance strategy across products and teams, helping ensure software is safe, effective, and supported by risk-based evidence throughout development and after release.

Responsibilities - Lead software quality, risk management, design control, and verification and validation practices across products and programs. - Direct risk assessments for software anomalies, cybersecurity vulnerabilities, emerging technologies, and post-market issues. - Review and approve lifecycle documentation, risk records, V&V protocols, and design history content. - Improve quality systems, development processes, automation, verification, validation, and compliance workflows. - Support digital transformation of lifecycle systems and assess changes in regulations, standards, and industry practice. - Advise senior leaders and cross-functional teams on risk-based decisions, product roadmaps, and quality strategy; mentor software quality engineers.

Requirements - Typically a technical bachelor’s degree and 8–12 years of related experience, or a master’s with 5–7 years, or a doctorate with 2–4 years of industry experience. - Extensive medical device experience and expertise in applicable requirements such as FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971, IEC 82304, and EU MDR. - Advanced knowledge of software lifecycle processes and development approaches, including Agile, Waterfall, DevOps, CI/CD, and test automation. - Ability to lead complex initiatives, make sound risk assessments, and influence decisions across engineering, quality, regulatory, clinical, and cybersecurity teams.

Benefits and work setup The role is designed for a home office and does not require living near a company site. A hybrid arrangement may be available for those within commuting distance; a flexible workplace option is also mentioned.