Senior Software Quality Engineer
Listed on 2026-06-08
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Software Development
Software Engineer
Senior Software Quality Assurance Engineer
Location: Fully Remote (U.S. Based)
Industry: Medical Devices | Neuromodulation | Class III Devices
We are an innovative medical device company developing next-generation neuromodulation technologies focused on treating epilepsy and sleep apnea. We’re looking for a Senior Software Quality Assurance Engineer to join a highly collaborative team working on cutting‑edge Class III implantable devices. This role goes beyond traditional QA; you will be deeply involved in software and firmware development from concept through commercialization, helping ensure products meet the highest standards for quality, safety, and regulatory compliance.
Responsibilities- Lead software quality activities across the full product development lifecycle.
- Own software risk management and design control documentation.
- Ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 820, and related regulatory standards.
- Chair change control activities for software defects, enhancements, and product updates.
- Provide technical feedback during code reviews and software/firmware investigations.
- Support CAPAs, root cause investigations, and audit responses.
- Serve as a subject matter expert during regulatory inspections and audits.
- Partner cross‑functionally with Engineering, R&D, Clinical, Regulatory, and Operations teams.
- 6+ years of experience in software or firmware quality within the medical device industry.
- Strong knowledge of IEC 62304, ISO 13485, FDA 21 CFR Part 820.
- Experience working in regulated product development environments.
- Strong communication skills with the ability to work across technical and non‑technical teams.
- Bachelor’s degree in Computer Science, Engineering, or a related field.
- Experience with implantable or Class III medical devices is a strong plus.
- Work on life‑changing technology that directly impacts patients.
- Join a mission‑driven company with strong technical leadership.
- Fully remote flexibility within the U.S.
- High‑visibility role with real influence across product development and quality strategy.
- Opportunity to work on highly innovative implantable medical technologies.
Salary Type: Annual Salary
Salary Minimum: $100,000
Salary Maximum: $140,000
Currency: USD
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