SunnyvaleFull TimeEngineering
Remotely
risk managementfda qsrsoftware development life cycledesign controlsiso 13485iso 14971electromechanical systems
Job Description
📋 Description
- Support product dev from concept to commercialization
- Lead design controls and risk management guidance
- Ensure SDLC compliance with quality processes
- Collaborate to transfer scalable designs to manufacturing
- Assist in supplier selection and design verification/validation
🎯 Requirements
- 8+ years in Quality Engineering; 4+ years in electromechanical or software design
- Strong design control and risk management background
- Experience with ISO 13485, ISO 14971, FDA QSR
- Ability to navigate quality systems with minimal oversight
- Excellent communication, ability to convey complex info to execs
