Principal Robotics Systems Engineer
US362 MA Boston - 501 Boylston St, United States
USD 117K-201K Senior-level Full Time
Tasks
- Define and maintain system interfaces and specifications
- Define software related system requirements and use cases
- Define system architecture and subsystem requirements
- Drive cross functional collaboration across hardware software controls mechanical clinical and V and V
- Drive design for reliability and conduct DoE
- Ensure compliance with FDA quality system and medical device standards
- Execute design control activities for regulatory compliance
- Investigate nonconformances deviations and test failures with root cause analysis
- Lead system architecture development and integration
- Lead system level design and architecture reviews
- Lead system level risk management with hazard analysis and residual risk
- Lead systems engineering for surgical robotic platform
- Own end to end requirements lifecycle and traceability
- Partner with human factors and clinical engineering for usability
- Support audits inspections and regulatory submissions
- Support design transfer and product launch and post market surveillance
- Support system level reliability analysis and accelerated life testing
- Use MBSE and UML to manage architecture requirements and interfaces
Perks/Benefits
- N/A
Skills/Tech-stack
21 CFR part 820 | Accelerated life testing | CAPA | CFR Part 820 | Cause analysis | DOE | Design Control | Design of Experiments | Design reviews | FDA 21 CFR | FDA 21 CFR Part 820 | Hazard Analysis | IEC 60601 | IEC 62304 | ISO 13485 | ISO 14971 | Interface specification | Life testing | Mbse | Model Based Systems Engineering | Model-based systems | Part 820 | Requirements Traceability | Risk Management | Root Cause Analysis | Root cause | System Architecture | Systems engineering | UML | Verification and Validation
Education
Regions
Countries
States
Cities
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