Senior Manufacturing Engineer

2 days ago


Minneapolis, Minnesota, United States FPC National Full time
Job Title: Senior Manufacturing Engineer

At FPC National, we are seeking a highly skilled Senior Manufacturing Engineer to support the development, qualification, and launch of new and updated medical devices.

Key Responsibilities:
  • Design and optimize manufacturing processes, procedures, and production layouts for drug-device products.
  • Enhance drug coating processes and equipment, prioritize improvements, and implement innovations.
  • Assist with project timelines and development plans.
  • Coordinate with teams for new product designs and updates, and provide training.
  • Participate in PFMEA, DFMEA, Process Mapping, and CTQ reviews.
  • Lead or support Design for Manufacturing (DFM) activities.
  • Create and review process flow charts, tooling strategies, line layouts, capacity analyses, and EHS plans.
  • Manage line validation and qualification activities, including IQ, OQ, MSA, and PQ.
  • Engage in Lean initiatives to improve production line stability and reduce transfer time.
  • Enhance manufacturing efficiency through workflow analysis, time studies, space planning, and equipment layout.
  • Write and oversee testing protocols and analyze product evaluation requests.
  • Develop process documentation, including Work Instructions and Control Plans.
  • Ensure quality by designing testing methods and establishing manufacturing standards.
  • Provide decision-making information on costs, production schedules, and future needs.
  • Prepare and summarize reports on product and process information.
  • Comply with Laborie QMS, ISO 13485, and other relevant standards.
  • Ensure equipment functionality by managing maintenance, repairs, and special services.
Requirements:
  • Master's or Bachelor's degree in Mechanical Engineering or related field with relevant experience.
  • Experience in lean manufacturing, ISO 13485/ISO 9001, medical device environments, manufacturing quality, and project management.
  • Knowledge of Design for Manufacturability (DFM), Six Sigma Green Belt, and Lean Six Sigma.
  • Experience with ERP systems.
  • 5% domestic and/or international travel potential.


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