Medical Device Sewing Specialist

4 weeks ago


Singapur, Singapore Edwards Lifesciences Full time
Job Summary

As a skilled Medical Device Sewing Specialist at Edwards Lifesciences, you will play a critical role in the production of medical devices, specifically cardiovascular devices. Your expertise in sewing tissue and non-tissue components will ensure the highest quality products that meet regulatory and company guidelines.

Key Responsibilities
  • Utilize specialized tools and equipment, such as needles, scissors, forceps, and microscopes, to perform assigned steps in the sewing assembly of stent/valves.
  • Verify completed steps against specifications, ensuring accuracy and quality.
  • Review and follow established work instructions and Standard Operating Procedures (SOPs), including recording traceable information on device history records.
  • Perform line clearance, cleaning and sanitizing workstations at the start of the shift and when transitioning to next work orders.
  • Conduct visual inspections under a microscope and review colleagues' work.
Requirements
  • Secondary education with previous sewing, GMP, clean room, and medical device experience preferred.
  • No previous related experience required.
  • Ability to use small hand tools, hand-eye coordination, and high manual dexterity.
  • Basic level of understanding of manufacturing procedures.
  • Basic computer skills preferred.
  • Good hand-eye coordination and ability to read, comprehend, and speak English required.
  • Ability to work in a team environment and with minimum supervision.
  • Successful completion of ongoing job training of assembly process steps.
  • Strict attention to detail and adherence to company rules and requirements.


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