Manufacturing Engineer

2 weeks ago

Minneapolis, 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.

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