Biomedical Manufacturing Engineer

3 weeks ago

Minneapolis, Minnesota, United States Cell Culture Company, LLC Full time

Cell Culture Company, LLC is currently seeking a Biomedical Manufacturing Engineer to join our team. This role will support the manufacture of bioreactor instruments, disposables, and accessories. As a Biomedical Manufacturing Engineer, you will identify and implement new and replacement parts to maintain current disposable and instrumentation product lines.

The ideal candidate will have experience meeting corporate goals related to production schedules, process optimization, cost control. You will collaborate with the account services, supply chain, quality, engineering, and accounting departments to maintain sustainability of our products, resolve issues, and ensure on-time delivery of quality products to our customers.

Duties and Responsibilities:
  • Create and update manufacturing and safety procedures.
  • Evaluate drawings, bill of materials, SOPs, and other documents when required to ensure they are accurate, clear, concise, and user-friendly.
  • Work with quality control to ensure all manufactured products are within specifications.
  • Work with the assemblers/technicians on the flow and function of the disposable and instrumentation manufacturing areas to enable high productivity and provide a safe working environment.
  • Contribute with hands-on work to meet production schedules as needed.
  • Prepare for and participate in customer and supplier audits.
  • Participate in CAPA investigation and resolution process.
  • Participate in new/replacement product design.
  • Facilitate the transition of new parts to production.
Requirements:
  • Strong leadership with excellent written and oral communication skills and the ability to maintain accurate documentation.
  • Familiarity with RoHS, CE, ISO, FDA, and other relevant regulations and classifications.
  • Experience manufacturing a complicated product line, preferably complex instrumentation and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
  • Demonstrated success in Lean Process Improvement.
  • Ability to read and revise drawings/schematics/BOMs and review document change orders.
  • Advanced ability to use computers to plan, execute, communicate, present, and analyze using Microsoft office suite and Solidworks.

This is a full-time position, and the estimated salary range is between $90,000 - $110,000 per year based on experience and qualifications. The location of this job is Minneapolis, MN, USA. If you are a motivated and detail-oriented professional looking to make a difference in the biomedical industry, please submit your application.

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