Lead Software Quality Engineer

Job description:

Now Hiring: Senior Software Quality Assurance Engineer
Fully Remote (U.S. Based)
Medical Devices | Neuromodulation | Class III Devices

Are you passionate about building technology that truly improves lives?

Were partnered with an innovative medical device company developing next-generation neuromodulation technologies focused on treating epilepsy and sleep apnea. Theyre looking for a Senior Software Quality Assurance Engineer to join a highly collaborative team working on cutting-edge Class III implantable devices.

This is not a traditional QA role. Youll 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.

What Youll Be Doing

• 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.

What Were Looking For

• Experience working in regulated product development environments.
• Strong communication skills with the ability to work across technical and non-technical teams.
• Bachelors degree in Computer Science, Engineering, or a related field.
• Experience with implantable or Class III medical devices is a strong plus.

Why This Opportunity Stands Out

• 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.

If youre excited by meaningful work, enjoy collaborating across teams, and have a passion for balancing innovation with compliance, lets connect.

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

Why is This a Great Opportunity:

• 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 Min : $ 100000

Salary Max : $ 140000

Currency Type : USD