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anteristech

27 days ago

Senior Process Development Engineer

Onsite Maple Grove, Minnesota, United States

tech ops - us

greenhouse

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Job description

You will lead the development and validation of manufacturing processes for transcatheter heart valves in Maple Grove, Minnesota. This role involves collaboration with various teams to ensure compliance and readiness for commercialization.

Details

  • Maple Grove, Minnesota, United States, work from office
  • $118,000 – $138,000 salary range
  • 5+ years of experience in Process Development or Manufacturing Engineering within Class III medical devices
  • No visa sponsorship available

The work

  • Plan and execute development and optimization of manufacturing processes for Class III transcatheter heart valves
  • Drive process characterization and improvements for commercial-ready valve manufacturing
  • Author and execute validation strategies in alignment with regulatory requirements
  • Develop manufacturing documentation including SOPs and work instructions