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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