Design Quality Engineer II - Hardware (Surgical Robotics)
Tasks
- Conduct root cause investigations for nonconformances and CAPAs
- Contribute to U.S. launch hyper care efforts
- Define inspection strategies for hardware performance and safety
- Develop DFMEA and conduct risk reviews
- Ensure electrical safety and compliance activities
- Lead design quality and risk management activities
- Maintain Product Risk Management File
- Participate in design reviews and change management
- Perform quality testing and statistical analysis
- Resolve issues with manufacturing teams
- Support complaint investigations and post-market activities
- Support design transfer and production readiness
- Support supplier qualification and supplier quality inputs
- Translate design and CTQ requirements into manufacturing controls
Perks/Benefits
- 401k plan with employer match
- Dental insurance
- Health insurance
- Health savings account
- Paid Holidays
- Paid time off
- Tuition assistance
- Vision insurance
Skills/Tech-stack
CAPA | Cause analysis | Change Management | DFMEA | Design for manufacturability | Design reviews | Electrical safety | IEC 60601 | Inspection Planning | JMP | Manufacturing controls | Medical Device | Medical device regulations | Minitab | Product Risk Management | Product risk | Risk Management | Root Cause Analysis | Root cause | Statistical Analysis | Supplier Quality
Education
Roles
Regions
Countries
States
Cities
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