Manufacturing Process Improvement Specialist

4 weeks ago


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

Manufacturing Engineer (Contract)

RESPONSIBILITIES

  • Developing, implementing, and continuously improving manufacturing processes to enhance yield, reduce costs, and improve productivity.
  • Representing Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
  • Conducting or managing process validations (IQ/OQ, OQ, PQ).
  • Troubleshooting production line issues related to yield, quality, and throughput.
  • Leading scaling up processes from development to full-scale manufacturing.
  • Supporting evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
  • Creating/updating manufacturing instructions, routings, bills of materials, and SOPs.

QUALIFICATIONS

  • Minimum 4-5+ years of experience of medical device manufacturing.
  • Experience with Design Transfer and Process Validations at external suppliers (CMO).
  • Write and execute associated validations.
  • Strong analytical and problem-solving skills (DOE, SPC, Six Sigma)
  • Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
  • Demonstrates ability to consistently meet proposed timelines, applying competent use of project planning and project management skills.
  • Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
  • Ability to effectively provide direction and support to external partners/suppliers.
  • Experience with electromechanical assemblies is preferred
  • Design for Manufacturing experience is preferred.
  • Fixture development experience is preferred.
  • Experience in early stage of product development is preferred.

EDUCATION

  • Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline
  • Six Sigma Certification.

A Medical Devices company located in MN is seeking a skilled Manufacturing Quality Engineer to join their team. The ideal candidate will have a strong background in medical device manufacturing, with experience in design transfer and process validations at external suppliers. They will be responsible for developing and implementing manufacturing processes to enhance yield, reduce costs, and improve productivity. The successful candidate will also have strong analytical and problem-solving skills, with knowledge of Class II/Class III medical device manufacturing and related quality system regulations. If you are a motivated and detail-oriented individual with a passion for quality and process improvement, we encourage you to apply for this exciting opportunity.



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