Medical Device Sewing Specialist
4 days ago
At Edwards Lifesciences, we are seeking a highly skilled Medical Device Sewing Specialist to join our team. This role will be responsible for applying skill and dexterity in the sewing of tissue and non-tissue components used to produce medical devices, in keeping with regulatory and company guidelines.
Key Responsibilities- Use tools such as needles, scissors, forceps, specialized tooling, microscope, magnifying lamp, and manufacturing execution system (MES) to perform assigned steps, in rotation, in the sewing assembly of stent/valves.
- Perform verifications against specifications of completed steps, of stent and/or valve.
- Review, follow, and perform job functions in compliance with established work instructions and adherence with standard operating procedures (SOPs), including recording traceable information on device history records, which may include entry into JD Edwards and any other systems, as required.
- Perform line clearance, i.e., cleaning and sanitizing work stations at the start of the shift and when transitioning to next work orders.
- Perform visual inspection under a microscope, and sequential review of colleagues' work.
We prefer candidates with secondary education and previous sewing, Good Manufacturing Practice (GMP), clean room, and medical device experience. No previous related experience is required.
Additional Skills and Qualifications- 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, required.
- Ability to read, comprehend, and speak English, and good communication skills, required.
- Must be able to work in a team environment and with minimum supervision by following detailed established manufacturing instructions.
- Successful completion of ongoing job training of assembly process steps.
- Strict attention to detail.
- Adhere to all company rules and requirements, including pandemic protocols, Environmental Health & Safety rules, and take adequate control measures in preventing injuries to themselves and others, as well as to the protection of the environment and prevention of pollution under their span of influence/control.
$65,000 - $85,000 per year, depending on location and experience.
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