Associate Heart Valve Specialist

Edwards Lifesciences (Singapore) Pte Ltd; Singapore; On-site; SGD 30,000 - 42,000; Full time

Job summary

Edwards Lifesciences (Singapore) Pte Ltd is seeking a diligent sewing assembly technician to support the manufacturing of stents/valves. You will use precision tools, microscopes, and MES systems to assemble components, while following SOPs and completing all traceable records in system logs.

The role requires good hand-eye coordination, high manual dexterity, and the ability to work in a team with minimal supervision, adhering to safety and quality protocols in a clean-room environment.

Qualifications

• Secondary education completed; sewing experience preferred.
• GMP/clean room/medical device experience preferred; none required.

Responsibilities

• Use tools (e.g. needles, scissors, forceps, specialized tooling, microscope, magnifying lamp, 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 SOPs, including recording traceable information on device history records, which may include entry into JDE and any other systems (e.g. MES), 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
• Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing

Skills

Manual dexterity

Hand-eye coordination

English communication

Teamwork

Attention to detail

Education

Secondary education

GMP experience preferred

Clean room experience preferred

Medical device experience preferred

Tools

Needles

Scissors

Forceps

Specialized tooling

Microscope

Magnifying lamp

MES

Job description

Performs sewing work to support manufacturing/production activities, following established procedures and guidance.

Key Responsibilities

• Use tools (e.g. needles, scissors, forceps, specialized tooling, microscope, magnifying lamp, 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 SOPs, including recording traceable information on device history records, which may include entry into JDE and any other systems (e.g. MES), 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
• Other incidental duties: General work area housekeeping, general sanitization of work area with approved chemicals, material handling, printing

Education and Experience

• Secondary Education with previous sewing, GMP, clean room, medical device experience preferred
• No previous related experience required

Additional Skills

• 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 (e.g., 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 environment and prevention of pollution under their span of influence/control