Experience: 10+ years
The Mechanical SME will ensure business continuity in product development, validation, and support for the Infusion Pump platform. The role requires expertise in part & product design, V&V activities, and manufacturing transfer.
Key Responsibilities:
Execute mechanical changes including part and product designs, BOM updates.
Support Sustenance Engineering and component obsolescence.
Lead V&V efforts including test protocol creation and test method validations.
Provide risk file updates for system and subsystem levels.
Support design transfer and manufacturing activities.
Coordinate with external vendors.
Mentor and support onboarding of new team members.
Additional Support Areas:
Participate in cross-functional discussions (TRB/CCB/CIT).
Conduct and support design reviews (Technical & Final).
Perform risk reviews (PRR, EBRR).
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