Software Design Quality Engineer

📋 Description

• Own software design control strategy and processes for implantable software and related systems.
• Collaborate with software/firmware teams to embed IEC 62304 practices.
• Lead risk assessments, verification/validation, and traceability activities.
• Develop and maintain DHF content, design plans, and requirement-to-test linkages.
• Support continuous improvement of compliance processes and templates.

🎯 Requirements

• Bachelor’s degree in CS, Software Eng, Biomed Eng, or related field.
• 3+ years in software design controls or quality for medical devices.
• Strong SDLC understanding in regulated/safety-critical contexts.
• Experience planning and documenting design control activities and verifications/validations.
• Working knowledge of IEC 62304, ISO 14971, ISO 13485.
• Cross-functional communication and issue resolution across teams.

🎁 Benefits

• Competitive benefits package with medical, dental, and vision insurance.
• Equity (RSUs) for full-time employees.
• Paid holidays and commuter benefits.
• Meals provided and 401(k) plan.
• Parental leave and flexible time off.