Associate Heart Valve Specialist

Edwards Lifesciences; Singapore; Hybrid; SGD 34,000 - 52,000; Full time

Job summary

Edwards Lifesciences is seeking a manufacturing operator to perform sewing assembly of stent and valve components under strict quality and regulatory guidelines. The role involves handling precision tools, conducting verifications, and recording traceable information in device history records.

Candidates should have secondary education, good English, and strong manual dexterity. The position requires the ability to work in a team, follow detailed manufacturing instructions, and participate in

Qualifications

• Requires basic proficiency in handling small hand tools and following manufacturing instructions.
• Must read, comprehend, and communicate in English.
• Strong manual dexterity and attention to detail are essential.
• Ability to work in a team and follow SOPs with minimal supervision.

Responsibilities

• Perform sewing assembly steps for stent/valves using precision tools.
• Verify completed steps against specifications and document results.
• Maintain compliance with SOPs, record traceable information in device history records or MES/JDE.
• Execute line clearance by cleaning and sanitizing workstations at shift start and during transitions.
• Conduct visual inspections under a microscope and review colleagues' work for quality.
• Perform general housekeeping and material handling as required.

Skills

Manual dexterity

English proficiency

Teamwork

Attention to detail

Education

Secondary education

Tools

Needles

Scissors

Forceps

Microscope

MES

Job description

Applies 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 (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 stepsStrict 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