Software Quality Engineer

What You'll 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.
• Serve as a subject matter expert during regulatory inspections and audits.
• Partner cross-functionally with Engineering, R&D, Clinical, Regulatory, and Operations teams.

What We're 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.

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