Job ID: #8610

Sr. Process Engineer

Sudbury
Science Science
GMP Manufacturing

Our client is Medical Device Start-up company (50 employees and growing) and they are looking for a Sr Process Engineer who has experience working with catheters.

Responsibilities:

  • Write and implement manufacturing processes and inspection procedures.
  • Troubleshoot basic manufacturing processes
  • Create and change bills of materials and assembly methods.
  • Write Validation and Qualification protocols.
  • Design and implement fixtures and other manufacturing aids.
  • Support prototype and pilot production of new products, product changes, and enhancements in coordination with Engineering and Quality Control functions.
  • Work with product development staff to ensure that products under development are optimally manufacture able and to resolve manufacturing issues.
  • Write equipment design and IQ/OQ/PQ
  • Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up.
  • Specify and procure necessary production equipment, fixtures, and tooling
  • Participate in the creation of Intellectual Property

Requirements:

  • Bachelor of Science Degree in Engineering, Manufacturing or Mechanical Engineering
  • 7+ years of experience working as a Process Engineer
  • 5+ years of Medical Device Industry experience
  • Vascular Catheter experience
  • ISO13485
  • Experience developing clean room operations procedures & protocols

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    Commonwealth Sciences is a professional recruiting firm specializing in Life Science, Medical Device, and Engineering Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.