Senior Software Quality 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. Qualifications 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. Benefits 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. Compensation Salary Type: Annual Salary Salary Minimum: $100,000 Salary Maximum: $140,000 Currency: USD #J-18808-Ljbffr