Lead site-level EU MDR implementation for Spine manufacturing, managing project execution, cross-functional coordination, regulatory deliverables, manufacturing readiness, risks, and fixed implementation timelines.
Job Responsibilities
Key Responsibilities
Lead EU MDR implementation activities, site execution plans, schedules, milestones, and deliverables.
Coordinate Manufacturing, Quality, Engineering, Supply Chain, Operations, and EU MDR program teams.
Manage ECO/MCO/SMECO execution, documentation updates, master data, and system readiness.
Track risks, constraints, dependencies, capacity issues, and develop mitigation plans.
Support audits, inspections, internal reviews, documentation, and regulatory traceability.
Provide manufacturing engineering support for machining, metal finishing, assembly, and process planning.
Communicate project status, risks, priorities, and readiness to site and program leadership.
Numbers & Facts
Location
Warsaw, IN
Job Type
Contractor
Salary
$80–$83 Per Hour
Qualifications
Required Skills & Qualifications
Bachelor’s degree in Engineering.
7+ years of relevant experience, including 5+ years in project management/site leadership; advanced degree with 5+ years relevant experience may also qualify.
Strong project/program management experience in manufacturing.
Experience leading regulated changes and coordinating cross-functional teams.
Strong knowledge of manufacturing processes and change control.
Desired Skills
Medical device or highly regulated manufacturing experience.
EU MDR or similar regulatory change program experience.
ECO/MCO/SMECO, manufacturing process planning, master data, labor standards, machining, metal finishing, and assembly experience.
Education
Bachelor’s degree in Engineering required.
About Company
Medical Device Manufacturing Company
Skills
Manufacturing Engineering
Skills
Cross-Functionalunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Requirementsunmatched
Medical Equipmentunmatched
Project Executionunmatched
Project/Program Managementunmatched
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