Mechanical Engineer

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).

Created: 2025-10-02