Key skills
Risk Management
About this role
Role Overview
- Support the definition, integration, and characterization of innovative product content
- Engage and actively contribute to system engineering activities within Life Cycle Engineering
- Collaborate with seasoned Systems Engineers on troubleshooting design issues and methods of improvement
- Collaborate with cross-functional project teams to achieve project deliverables
- Contribute to design changes for subsystems including requirement refinement, risk reviews, risk mitigations, and system verification plans
- Support functional analysis, timeline analysis, and detailed trade-off studies
- Contribute to troubleshooting system-level issues and root cause analysis
- Contribute to risk management activities, including hazard identification and FMEA
- Work closely with regulatory affairs and quality assurance teams for regulatory submissions
- Author engineering build requests and design protocols
Requirements
- Bachelor degree required (preferred field of study: Biomedical, Electrical, Mechanical, Systems)
- 1+ years of experience working in the medical device industry/ high regulated product development industry
- 1+ years of experience working directly in a Systems Engineering discipline within product development
- Demonstrates working knowledge of engineering principles and scientific methods
- Hands-on and inquisitive, not being afraid to challenge a design
- General understanding of medical devices and regulations
- Planning and organization skills
- Ability to organize and judge priorities in a dynamic environment
- Strong technical writing ability
- Experience with lab equipment (testing)
- Microsoft office suite (Word, Excel, PowerPoint)
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs