Design Quality Engineer II - Hardware (Surgical Robotics)
USA-CT North Haven, United States
USD 79K-118K Mid-level Full Time
Tasks
- Conduct electrical safety risk identification and test strategy alignment
- Define inspection strategies for hardware performance and safety
- Develop DFMEA and conduct risk reviews
- Incorporate serviceability reliability and field maintenance into design
- Lead CAPA and nonconformance investigations
- Lead design quality and risk management activities
- Maintain Product Risk Management File elements
- Participate in design reviews and change management
- Perform quality testing statistical analysis and root cause investigations
- Perform supplier qualification and supplier quality inputs
- Resolve manufacturing and quality issues
- Support complaint investigations and post market hyper care efforts
- Support design transfer and production readiness
- Support quality activities for capital equipment and electromechanical systems
- Translate design and CTQ requirements into manufacturing controls
Perks/Benefits
- Dental insurance
- Health insurance
- Health savings account
- Life insurance
- Long-term disability
- Tuition assistance
- Tuition reimbursement
- Vision insurance
Skills/Tech-stack
CAPA | Capital equipment | Cause analysis | Change Management | Complaint handling | CtQ | DFMEA | Design quality | Design reviews | Electrical safety | Electromechanical Systems | IEC 60601 | Inspection Planning | JMP | Manufacturing controls | Market surveillance | Medical Devices | Minitab | Post-Market Surveillance | Product Risk Management | Product risk | Quality testing | Reliability Engineering | Risk Management | Root Cause Analysis | Root cause | Serviceability | Statistical Analysis | Supplier Quality | Supplier qualification
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
Roles
Regions
Countries
States
Cities
Language: en
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