Senior Manufacturing Engineer - EU MDR Project / Site Lead
Warsaw, IN (onsite)
We're seeking an experienced Manufacturing Engineer / Project Manager to lead EU MDR implementation activities at a manufacturing site. This role will coordinate cross-functional teams and drive execution against fixed regulatory timelines.
Required Technical skills- Project or program management experience within a manufacturing environment
- Understanding of manufacturing processes, change control, and cross-functional coordination
- Ability to operate effectively within fixed regulatory deadlines and constrained schedules
Responsibilities- Lead site-level EU MDR implementation activities and execution plans
- Manage project schedules, milestones, risks, and mitigation plans
- Coordinate across Manufacturing, Quality, Engineering, Supply Chain, and Operations
- Drive engineering/change-control activities, documentation updates, and system readiness
- Support manufacturing process improvements, quality, cost, and schedule performance
- Provide shop-floor support for machining, metal finishing, and assembly processes
- Ensure compliance and readiness for audits, inspections, and internal reviews
Required Experience- Bachelor's degree in Engineering required
- Strong project/program management experience in a manufacturing environment
- Experience with regulated manufacturing and change control
- Ability to manage complex, cross-functional projects under tight regulatory deadlines
- Strong communication, coordination, and problem-solving skills
#LI- DR2
