Manager, Systems Engineering
Insulet(2 months ago)
About this role
The Manager, Systems Engineering at Insulet leads and growing systems engineering team responsible for system-level hardware and software across product lifecycle for the Omnipod platform. The role focuses on enabling technical risk reduction, lifecycle management, post-market support and ensuring compliance within a QMS-regulated medical device environment.
Required Skills
- Systems Engineering
- Lifecycle Management
- Risk Analysis
- Root Cause Analysis
- CAPA Execution
- Obsolescence Planning
- V&V
- Regulatory Compliance
- Traceability
- Change Management
+4 more
Qualifications
- BS in Systems/Related Engineering
- MSc or PhD (Preferred)
- Six Sigma Certification (Preferred)
- Knowledge of ISO 13485
- Knowledge of ISO 14971
- Knowledge of IEC 62304
- Knowledge of FDA 21 CFR Part 820.30
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