Project Engineer, Process Development

Mike Callaway Engineering, Manufacturing

  • Full Time
  • Lakeland, FL
  • Applications have closed

Website Stryker

Medical reprocessing and remanufacturing is good for the environment and a hospital’s bottom line. We provide financial and environmental sustainability through single-use device reprocessing.

If you want to be part of the market leader for reprocessing and remanufacturing services in medical devices read below because we are searching for a talented Engineer to join our Advance Operations team.

This person will Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
Main Responsibilities:

  • Ensure quality of process and product as defined in the appropriate operation and material specifications.
  • Communicate and work with Design/R&D, Regulatory, Quality, etc to improve processes
  • Design new process and equipment and/or assist in the selection of components and equipment based on analysis of specifications and reliability with particular focus on disassembly, cleaning and assembly of medical devices.
  • Analyze equipment to establish operating data, conduct experimental tests and result analysis.
  • Participate in process review meetings.
  • Lead PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
  • Complete capability studies for in-process inspection and generate subsequent inspection documentation.
  • Conduct MSA studies for new products and new processes.
  • Ensure adherence to GMP and safety procedures.

Minimum Qualifications

  • B.S in Engineering, Materials Science, Chemistry or related discipline with up to 2 years’ experience
  • Knowledge or experience with Ultrasonic cleaning technology and Enzymatic cleaner and surfactant chemistry would be preferred.
  • Experience with sterility assurance is also preferred.

Stryker is acting as an Employment Agency in relation to this vacancy.