Description
Completes drafting, compilation and project management of design control records and reports associated with the design history file applicable to a pre-filled syringe.
SKILLS:
Most important skills:
- 7+ years design experience
- Device design controls
- Writing risk management documents including complaint analysis
- User task analysis
- uFMEA, dFMEA
- Pre-filled syringe human factor study.
- Both pharma and device experiences required.
- Safety and Risk Management