Job Title: Sr Manufacturing Engineer
Client: Medical Device Manufacturing Company
Duration: 12 Months – Possible Extension
Location: Warsaw, IN 46582, USA
Shift: 1st Shift
Work Arrangement: Site-Based
Description:
Job Summary
The Sr Manufacturing Engineer – Exempt will serve as the EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer – Spine, responsible for leading and coordinating EU MDR implementation activities at the manufacturing site.
This role will manage site-level execution, coordinate cross-functional teams, track regulatory deliverables, resolve execution risks, and ensure manufacturing readiness within fixed regulatory deadlines.
Top 3 Technical Skills
- Project/program management experience in a manufacturing environment.
- Strong understanding of manufacturing processes, change control, and cross-functional coordination.
- Ability to manage projects effectively within fixed regulatory deadlines and constrained schedules.
Key Responsibilities
- Lead and manage Spine EU MDR implementation activities at the assigned manufacturing site.
- Own site-level execution plans, schedules, milestones, and deliverables.
- Serve as the primary liaison between the EU MDR Program Team and site Manufacturing leadership.
- Coordinate execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations.
- Ensure site readiness, including ECO/MCO/SMECO execution, documentation updates, and system readiness.
- Track milestones, identify risks and constraints, and develop mitigation plans.
- Escalate execution issues, capacity constraints, and dependency risks.
- Support audits, inspections, and internal reviews by maintaining proper documentation and traceability.
- Ensure adherence to standardized MDR implementation processes while addressing site-specific constraints.
- Translate program-level EU MDR strategy into executable site-specific plans.
- Coordinate entry and maintenance of master data for assigned product lines.
- Provide shop-floor support for manufacturing methods and processes involving machining, metal finishing, and assembly.
- Maintain Manufacturing Process Planning documentation and ensure accurate labor standards.
- Identify and implement improvements to manufacturing methods and processes to improve quality, schedule performance, and manufacturing costs.
- Coordinate resources, sequencing, and issue resolution with significant autonomy.
- Serve as the site owner for MDR implementation performance and readiness.
- Communicate implementation status, risks, mitigation plans, and priorities to site and program leadership.
- Influence cross-functional teams to align priorities, resolve conflicts, and maintain execution momentum.
Required Qualifications
- Bachelor’s degree in Engineering required.
- 7+ years of relevant experience, including 5+ years in project management or site leadership roles; OR
- Advanced degree with 5+ years of relevant experience and 5+ years of project/site leadership experience.
- Strong project or program management experience within a manufacturing environment.
- Experience leading site-based execution of regulated changes, preferably within regulatory, quality, engineering, or operations.
- Strong understanding of manufacturing processes and change control.
- Experience coordinating across multiple cross-functional teams.
- Ability to manage work within fixed regulatory deadlines and constrained schedules.
Preferred Experience
- Experience in a medical device or other highly regulated manufacturing environment.
- Experience with EU MDR implementation or similar regulatory change programs.
- Experience with engineering change processes such as ECO/MCO/SMECO.
- Experience supporting manufacturing operations involving machining, metal finishing, and assembly.
- Experience with manufacturing process planning, master data, and labor standards.
Work Environment
- Site-based manufacturing environment
- Significant interaction with Manufacturing, Quality, Engineering, Supply Chain, Operations, and program leadership
- Role requires the ability to manage complex, interdependent activities while maintaining compliance and meeting fixed implementation timelines.
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