Process /Manufacturing Engineer - Medical Device Industry

TechtrueupCincinnati, OH
10hOnsite

About The Position

Seeking a Contract Process Engineer to support the design, development, optimization, and scale-up of manufacturing processes for medical device and drug-delivery components. The contractor will work with cross-functional teams and suppliers to deliver robust, manufacturable solutions.

Requirements

  • 6+ years in process development within a regulated industry.
  • Strong understanding of component fabrication and assembly processes.
  • Experience with DFMA, FMEA, and applied statistics (MSA, process capability).
  • Experience with equipment commissioning (debug, characterization, FAT, validation).
  • Familiarity with Lean, Six Sigma, or similar methodologies.

Nice To Haves

  • Experience supporting commercialization or working with global teams/suppliers.
  • Prior J&J or MedTech experience is strongly preferred.
  • Travel to Mexico / Ireland

Responsibilities

  • Develop, optimize, and validate component and assembly manufacturing processes.
  • Support DFM/A activities and translate product requirements into process outputs.
  • Conduct process characterization, capability studies, and statistical analyses.
  • Partner with R&D, Quality, Regulatory, Supplier Engineering, and Operations throughout development.
  • Support equipment debug, characterization, FAT, and qualification activities.
  • Troubleshoot manufacturing and compliance issues and support process transfer to production sites.
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