Sr Manufacturing Engineer

Job Description

Job Description

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.

#ZR \nCompany Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.

Company Description

As a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.