Manufacturing Process Improvement Specialist

6 days ago


Minneapolis, Minnesota, United States a Medical Devices company located in MN Full time
Job Title: Manufacturing Quality Engineer

At a Medical Devices company located in MN, we are seeking a highly skilled Manufacturing Quality Engineer to join our team.

Responsibilities:
  • Process Development and Improvement: Develop, implement, and continuously improve manufacturing processes to enhance yield, reduce costs, and improve productivity.
  • Technical Expertise: Represent Process Engineering in R&D and Project Team meetings, providing technical expertise in technology transfers, analytical method development, validation, and process scale-up.
  • Process Validation: Conduct or manage process validations (IQ/OQ, OQ, PQ).
  • Troubleshooting: Troubleshoot production line issues related to yield, quality, and throughput.
  • Process Scaling: Lead scaling up processes from development to full-scale manufacturing.
  • Quality Support: Support evaluation of NCMR, CAPA, SCAR, Failure Investigation, and Deviation requests from Contract Manufacturers/Suppliers.
  • Documentation: Create/update manufacturing instructions, routings, bills of materials, and SOPs.
Qualifications:
  • Experience: Minimum 4-5+ years of experience in medical device manufacturing.
  • Design Transfer and Process Validations: Experience with Design Transfer and Process Validations at external suppliers (CMO).
  • Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills (DOE, SPC, Six Sigma).
  • Regulatory Knowledge: Knowledge on Class II/Class III medical device manufacturing and related quality system regulations.
  • Communication Skills: Excellent oral and written communication skills; ability to communicate with technical and non-technical audiences.
  • Leadership Skills: Ability to effectively provide direction and support to external partners/suppliers.
  • Preferred Qualifications: Experience with electromechanical assemblies, Design for Manufacturing, and Fixture development.
Education:
  • Bachelor's Degree: Bachelors in Biomedical, Manufacturing, Mechanical Engineering, or related life sciences discipline.
  • Certification: Six Sigma Certification.


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