Medical Device Program Management (FDA / ISO 13485 environment)
Title: Medical Device Program Management (FDA / ISO 13485 environment)
Location: Greater Merrimack Area, NH (Hybrid 3 days onsite)
Employment Type: Contract
Status: Accepting Candidates
Overview
Seeking an experienced Operations Program Manager to support build-to-print and sustaining activities for complex products in an FDA-regulated environment. This role will lead transition and sustaining programs, coordinate cross-functional teams, and ensure continuity of supply across the product lifecycle.
Key Responsibilities
Act as primary customer interface for operations, production commitments, and PO coverage
Lead sustaining engineering, product transition, and lifecycle management projects
Coordinate cross-functional work across Engineering, Supply Chain, Procurement, and Operations
Maintain product portfolio roadmap and support new product introduction activities
Drive continuity of supply, cost reduction, and operational readiness
Prepare project status reports and support business reviews and steering meetings
Qualifications
Bachelor's degree in Engineering and/or Operations
Experience with medical devices in an FDA-regulated environment
Proven program management experience with electro-mechanical or instrumentation products
Experience supporting product transfer, sustaining, or lifecycle programs
Familiarity with ISO 13485 and regulatory compliance requirements
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