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About the role
Job Title: Manufacturing Engineer Location: Warsaw, IN (Onsite) Job Type: Contract Visa Requirements: H1B, USC, GC
Job Description:
We are seeking an experienced Manufacturing Engineer to support our medical device manufacturing operations. The ideal candidate will possess a strong background in cleaning and upgrade validations, equipment and process qualifications, and process improvement in a regulated environment.
Minimum Education:
Bachelor’s Degree in Engineering or a related technical field
Essential Duties and Responsibilities:
Perform cleaning and upgrade validations in medical device manufacturing
Execute and support equipment IQ/OQ , process OQ/PQ , and test method validations
Conduct Gage R&R studies and support process characterization
Lead root cause analysis and implement effective corrective actions
Create and update BOMs and Routers
Interpret and utilize engineering drawings to support production and process development
Apply risk analysis tools (e.g., PFMEA) and Critical-to-Quality (CTQ) concepts
Ensure compliance with FDA QSR , ISO 13485 , and cGMP standards
Support and participate in design control activities
Utilize Statistical Process Control (SPC) techniques and tools for data-driven improvements
Other Skills and Abilities:
Proficient in Change Management Systems , Nonconformance Reports (NCRs) , CAPA , Engineering Specifications , and Work Instructions
Knowledge of CNC programming terminology and tooling design
Strong communication and interpersonal skills (verbal & written)
Demonstrated ability to manage multiple projects in a fast-paced environment
Skilled in Microsoft Office Suite and Microsoft Project
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