Manufacturing Engineer /

EU MDR Site Lead Location:

Warsaw, IN Pay:

$60-80/hour

DOE Duration:

12-month contract

Schedule:

Full-time, onsite A leading medical-device manufacturer is seeking an experienced Manufacturing Engineer to lead site-level EU MDR implementation activities. This is a hands-on, cross-functional role for someone who can translate program requirements into executable manufacturing-site plans while keeping quality, regulatory and operational deliverables on track. What you'll do Lead EU MDR implementation activities at an assigned manufacturing site Own site execution plans, schedules, milestones and risk-mitigation activities Coordinate Manufacturing, Quality, Engineering, Supply Chain and Operations teams Drive ECO, MCO and SMECO execution, documentation updates and system readiness Serve as the main site contact for program leadership and manufacturing leadership Identify schedule, capacity and dependency risks and escalate issues when needed Support audits, inspections and internal reviews with accurate, traceable documentation Provide manufacturing-process support for machining, metal finishing and assembly operations Improve manufacturing methods to strengthen quality, schedule performance and cost Job Requirements Bachelor's degree in an Engineering discipline 7+ years of relevant experience, including 5+ years in project management, program management or site leadership Manufacturing project/program leadership experience Experience leading regulated changes in a manufacturing environment Strong understanding of manufacturing processes, change control and cross-functional coordination Experience working with fixed regulatory deadlines and constrained schedules Preferred Experience EU MDR implementation Medical device, orthopedic, spine or other highly regulated manufacturing ECO, MCO or SMECO execution Audit readiness, documentation control and traceability Manufacturing process planning and continuous improvement If you have the manufacturing leadership and change-control background to drive high-impact compliance work, apply today.

Job Disclaimer:

Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria.

Disclaimer:

These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #

GRPA 1647093

Manufacturing Engineer Site Lead Pay:

$60.00 - $70.00 per hour People with a criminal record are encouraged to apply Application Question(s): Do you have a bachelor's degree in an Engineering discipline? Do you have at least 7 years of relevant manufacturing, engineering or regulated-industry experience? Do you have at least 5 years of project management, program management or site-leadership experience? Have you led projects within a manufacturing environment? Do you have experience with manufacturing change control, such as ECOs, MCOs or SMECOs? Have you led regulated changes involving Quality, Engineering, Operations or Regulatory teams? Do you have experience coordinating Manufacturing, Quality, Engineering, Supply Chain and Operations stakeholders? Do you have EU MDR or medical-device manufacturing experience?

Work Location:

In person