Software Design Control Engineer

📋 Description

• Author, review, and maintain design control docs (SRS, Architecture, Traceability).
• Ensure software processes align with IEC 62304, ISO 13485, and FDA 21 CFR Part 820.
• Create and maintain software risk management files per ISO 14971 (FMEA).
• Produce software verification and validation (V&V) protocols and reports.
• Compile software documentation for regulatory submissions.
• Maintain post-market software documentation (surveillance, CAPAs, updates).

🎯 Requirements

• 5+ years in medical device software (Class II/III).
• BS in CS/BME/Software Eng or equivalent.
• Experience writing/maintaining DHF and traceability matrices.
• Proven track record taking device software through FDA clearance and launch.
• Standards: IEC 62304, ISO 14971, FDA Software Validation.
• Git, Jira; quality tools (Greenlight Guru, Arena, Jama).

🎁 Benefits

• Cutting-edge projects improving patients' lives.
• Competitive compensation and stock options.
• Comprehensive benefits package.
• 401(k) with matching contributions.