Related skills
sql python traceability iso 14971 iec 62304📋 Description
- Design and implement scalable software design controls per IEC 62304 and 21 CFR 820.30
- Build end-to-end traceability: needs, software requirements, risk, design, V&V evidence
- Integrate software risk management with design controls per ISO 14971
- Create change control to support rapid iteration, parallel development, same-day deployment
- Partner with software teams to embed CI/CD, automated evidence, and controlled releases
- Own software design control subsystems: design controls, software risk, change control, and V&V traceability
🎯 Requirements
- Bachelor’s degree in Electrical Engineering, CS, or related field
- Experience designing or maintaining structured engineering or compliance systems
- Familiarity with software lifecycles in regulated or safety-critical environments
- Working knowledge of Design Controls, software requirements management, and scripting (Python/SQL)
- Excellent written and verbal communication
- Strong systems-thinking problem-solver
🎁 Benefits
- Work with smart, talented experts from diverse fields
- Growth potential and fast advancement
- Excellent medical, dental, and vision insurance
- Paid holidays and commuter benefits
- Meals provided; equity (RSUs) for full-time employees
- 401(k) plan and parental leave
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