Software Design Quality Engineer
$103,000–$191,000 year
On-siteAustin, Texas, United States
Job Summary
Own software design control strategy, processes, and documentation across implantable electronics, surgical robotics, and external systems. Work directly with software and firmware teams to identify lifecycle risks early, drive robust mitigations, and support design reviews to embed IEC 62304 practices. Evaluate design change impacts on requirements, architecture, and traceability; determine re-test needs and update risk assessments, protocols, and Design History File content. Execute end-to-end design control activities for Class III regulated software in accordance with ISO 14971 and ISO 13485 standards. Debug quality gaps using requirements management tools, traceability matrices, and root-cause analysis to recommend process and design mitigations. Develop and maintain deliverables including design plans, verification/validation reports, and change control records for complex systems. Stay current with medical device software standards to contribute to continuous improvement of compliance processes and knowledge sharing.
Required Qualifications
- Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline
- 3+ years of hands-on experience with software design controls, software quality, or software design assurance for medical devices
- Strong understanding of the software development lifecycle (SDLC) in regulated or safety-critical environments and practical application of design controls
- Direct experience planning, executing, reviewing, and documenting software design control and verification/validation activities
- Working knowledge of IEC 62304 (Medical Device Software Lifecycle Processes), ISO 14971 (Risk Management), and ISO 13485
- Strong cross-functional communication skills and ability to drive issues to closure across engineering, quality, regulatory, and external partners
Desired Qualifications
- Experience with implants, surgical robotics, wireless systems, or Software as a Medical Device (SaMD) / Software in a Medical Device (SiMD)
- Prior experience contributing software design control or V&V data to regulatory submissions (IDE, 510(k), PMA, or equivalent) and interfacing with FDA or notified bodies
- Experience with medical device design controls, ISO 14971 risk management (including software FMEA / SFMEA), cybersecurity risk assessment, and product development lifecycle in a regulated environment
- Experience developing software design control guidelines, training programs, templates, or compliance workflows that accelerate product development
- Familiarity with additional standards such as IEC 62366 (usability), 21 CFR Part 11, or cybersecurity guidance (FDA, IEC 81001-5-1)
- Experience writing test protocols, reports, deviations, engineering rationales, risk assessments, and requirement traceability in a regulated or quality-controlled development process
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