Assembly Technician

About the role

Responsible for performing manual electro-mechanical assembly of medical devices within a GMP-controlled environment, ensuring all products are built, verified, and documented in accordance with approved work instructions, engineering specifications, and ISO 13485 quality requirements.

Key responsibilities

• Perform manual electro-mechanical assembly of medical device components and sub-assemblies in accordance with approved work instructions, engineering drawings, and bills of materials (BOM), within a GMP-controlled environment.
• Assemble mechanical, electrical, and electronic components using hand tools, torque tools, soldering/crimping equipment, and small power tools.
• Perform basic wiring, cable routing, and connector assembly to specification.
• Perform routine tools and equipment verification checks (e.g., torque drivers, gauges, jigs, and fixtures) prior to and during production to confirm calibration status and proper function.
• Report equipment malfunctions, out-of-calibration tools, or process deviations to the Manufacturing Engineer or Quality Engineer immediately.
• Maintain accurate production checklists and traveler records in real time and in full compliance with ISO 13485 best practices and applicable GMP requirements.
• Complete Device History Record (DHR) documentation and lot/serial number traceability records accurately and legibly.
• Perform in-process and final visual/functional inspections to verify conformance to specifications.
• Identify, segregate, and document non-conforming material or product per established procedures.
• Maintain a clean, organized, and GMP-compliant work area in accordance with 5S and housekeeping standards.

About you

• Technical Diploma or ITE certification in Mechanical Engineering, Mechatronics, or Automation.
• 1+ year(s) of hands-on assembly experience, preferably within a regulated medical device, electronics, or precision manufacturing environment.
• Proficient in spoken, read, and written English.
• Ability to read and interpret engineering drawings, BOMs, and work instructions.
• Working knowledge of electro-mechanical assembly techniques (soldering, crimping, torque application, wiring/cable routing).
• Familiarity with ISO 13485 and GMP documentation practices, including traveler records and DHR.
• Competent in using and verifying hand tools, torque drivers, and precision measuring/gauging equipment.
• Good manual dexterity, hand-eye coordination, and attention to detail.
• Basic computer literacy for entering data into ERP/MES/QMS systems.