Manufacturing Engineer II

3 weeks ago

Minneapolis, United States a Medical Devices company located in MN Full time

Responsibilities

  • Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and boost productivity.
  • Represent Process Engineering in R&D and Project Team meetings, offering technical expertise in technology transfers, analytical method development, validation, and process scale-up.
  • Conduct or manage process validations, including IQ/OQ, OQ, and PQ.
  • Troubleshoot production line issues related to yield, quality, and throughput.
  • Lead the scale-up processes from development to full-scale manufacturing.
  • Support the evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
  • Create and update manufacturing instructions, routings, bills of materials, and SOPs.

Qualifications

  • Minimum of 4+ years of experience in medical device manufacturing.
  • Experience with Design Transfer and Process Validations at external suppliers (CMO).
  • Proficiency in writing and executing associated validations.
  • Strong analytical and problem-solving skills (DOE, SPC, Six Sigma).
  • Knowledge of Class II/Class III medical device manufacturing and related quality system regulations.
  • Proven ability to consistently meet proposed timelines, utilizing project planning and project management skills effectively.
  • Excellent oral and written communication skills; ability to communicate with both technical and non-technical audiences.
  • Ability to effectively provide direction and support to external partners/suppliers.
  • Preferred experience with electromechanical assemblies.
  • Preferred experience with Design for Manufacturing.
  • Preferred experience in fixture development.
  • Preferred experience in the early stages of product development.

Education

  • Bachelor's degree in Biomedical, Manufacturing, Mechanical Engineering, or a related life sciences discipline.
  • Six Sigma Certification is a PLUS

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