Senior Quality Engineer
$115,000–$150,000 year
On-siteAlameda, California, United States
Job Summary
Build and document core software quality processes, including design control procedures, traceability practices, and review workflows that scale with the company. Contribute to design input/output reviews and verification/validation activities while maintaining the software risk management file with hazard-to-requirement traceability. Review software development plans and lifecycle deliverables against IEC 62304, lead safety classifications, and support source control audits. Own third-party software evaluation and premarket cybersecurity documentation reviews, plus support ML model lifecycle quality checks. Assist with internal and FDA audits, root-cause analysis, and CAPA for software defects. This role helps stand up the quality function from the ground up within Epia Neuro's neural technology team focused on restoring function for neurological conditions.
Required Qualifications
- Bachelor's degree required, preferred in a related field such as Biomedical Engineering, Computer Science/Software Engineering, Electrical Engineering, Systems Engineering, Quality Engineering, or Industrial Engineering.
- 5+ years of experience in medical device software quality engineering, including hands-on work with IEC 62304 lifecycle deliverables for Class C software.
- Working knowledge of ISO 13485 quality systems and design and development documentation.
- Experience contributing to risk management (ISO 14971) processes within the scope of medical device software.
- Comfortable raising quality concerns directly with engineering teams and holding a position under pressure while partnering constructively to help identify and define appropriate solutions.
Desired Qualifications
- Experience with Class III or active implantable medical device products.
- Familiarity with usability engineering (IEC 62366) documentation for medical device software.
- Exposure to medical device cybersecurity documentation (FDA premarket expectations, SBOM).
- Familiarity with AI/ML in medical devices (Good Machine Learning Practice principles)
- Exposure to agile software development in a regulated context (AAMI TIR45).
- Previous role at a fast-paced medical device startup.
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