Senior Manufacturing Engineer Jobot
Warsaw, IN4 days ago
Highlights
Lead site-level EU MDR implementation for Spine manufacturing, managing project execution, cross-functional coordination, regulatory deliverables, manufacturing readiness, risks, and fixed implementation timelines. Client: Medical Device Manufacturing Company .
Numbers & Facts
| Location | Warsaw, IN |
| Job Type | Contractor |
| Salary | $80–$83 Per Hour |
Description
Job Title: Sr. Manufacturing Engineer
Client: Medical Device Manufacturing Company
Duration: 12 Months Contract
Location: Warsaw, IN 46582
Shift: 1st Shift
Job Summary
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.
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.
Skills
About Company
Medical Device Manufacturing Company
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