Sr Manufacturing Engineer

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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