Perfusion Set Manufacturing Manager

Transmedics Andover , MA 01810

Posted 2 months ago

  • Oversee production of Transmedics Organ Care System Perfusion Sets.
  • Supervise team of production personnel responsible for producing Perfusion Sets. This includes hiring, developing, scheduling and directing employees, communicating expectations, managing performance and addressing questions or concerns.
  • Lead efforts to ensure all production and test related activities are executed in a timely manner to satisfy the Companys production schedule and quality standards (cGMPs, QSR and ISO requirements). Monitor the accuracy, completeness and timeliness of manufacturing processes.
  • Ensure Production team members are appropriately trained for assembly and test activities, as well as on company Standard Operating Procedures as required.
  • Identify opportunities to streamline production processes and remove inefficiencies through process, test and product design changes.
  • Support processes associated with manufacturing including material flow, inventory control and production documentation.
  • Develop and provide reports for key production metrics.
  • Ensure production areas are maintained in an orderly manner, production documentation is accurate and up to date and that production and test equipment are properly maintained and calibrated.
  • Work with Supply Chain, Quality and Production personnel to resolve component issues and expedite materials through the inspection and production processes.
  • Work with Technical team to identify and resolve technical and quality related issues identified in production.
  • Work with Engineering team to ensure TransMedics products are designed based on DFM, testability and post distribution serviceability considerations and that product adheres to performance, cost and quality requirements.
  • Support Facility related activities as required.
  • Perform other TransMedics tasks and duties as required.

Requirements

  • Bachelor of Science in Engneering or Operations Management plus a minimum of 8-10 years experience working in a Manufacturing Environment.
  • Must have manufacturing experience in FDA/ISO regulated Medical Device/ Medical Equipment Industry.
  • Must be detail oriented with strong organizational skills.
  • Must possess strong leadership and interpersonal skills with willingness to be held accountable for deliverables.
  • Must have outstanding ability to communicate clearly and effectively.
  • Must have effective analytical and decision making skills.
  • A proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities is required.
  • Must have the ability to identify, prioritize and resolve issues as they arise with minimal supervision.

Benefits

  • Medical
  • Dental
  • Vision
  • Short Term & Long Term Disability
  • Life Insurance
  • Flexible Spending Accounts
  • Company Holidays
  • Vacation
  • 401(k)
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