Medical Device Assembly Technician

Job Description : Medical Device Assembly Technician

1. Position Details

Job Title: Medical Device Assembly Technician
Department: Production
Reporting To: Production Supervisor / Quality Engineer
Location: Manufacturing Facility
Employment Type: Full-Time

2. Job Purpose
To carry out the assembly, soldering, sealing, functional testing, inspection, and packaging of medical devices in accordance with approved drawings, work instructions, SOPs, quality requirements, and applicable regulatory requirements.
The role is responsible for ensuring that each assembled device meets defined quality, safety, functionality, cleanliness, and traceability requirements before release to the next production stage or finished-goods inventory.

3. Key Responsibilities

A. Medical Device Assembly

• Assemble medical devices and sub-assemblies as per approved drawings, BOMs, SOPs, and work instructions.
• Handle electronic, mechanical, plastic, cable, connector, sensor, and other device components carefully.
• Verify component identification, quantity, orientation, and condition before assembly.
• Maintain proper ESD controls while handling electronic components and assemblies.
• Use approved tools, fixtures, jigs, and equipment.
• Ensure correct fitment, alignment, fastening, routing, and connection of components.
• Record required assembly and production information for traceability.

B. Soldering

• Perform through-hole and/or wire soldering operations as applicable to the product.
• Follow approved soldering work instructions and defined soldering parameters.
• Inspect solder joints for proper wetting, bonding, cleanliness, and absence of defects such as:
• Cold solder joints
• Solder bridges
• Insufficient solder
• Excess solder
• Cracked or damaged joints
• Loose wires or terminals
• Maintain soldering equipment and workstations in proper condition.
• Use approved soldering materials and consumables.
• Perform rework only in accordance with approved procedures.

C. Sealing and Enclosure Assembly

• Perform device enclosure closing and sealing operations according to approved procedures.
• Apply adhesives, sealants, gaskets, tapes, or other sealing materials as specified.
• Ensure correct quantity, application, curing, and positioning of sealing materials.
• Verify that the assembled device has no visible gaps, improper bonding, contamination, or damage.
• Maintain defined curing/setting conditions where applicable.
• Prevent contamination or damage to internal electronic and medical-device components during sealing.

D. Testing and Inspection

• Perform in-process and final functional testing as defined in the approved test procedure.
• Operate electrical/electronic test equipment, fixtures, and software interfaces as required.
• Check applicable parameters such as:
• Power-up/functionality
• Electrical performance
• Display/interface operation
• ECG/waveform functionality, where applicable
• Sensor and cable connectivity
• Battery/charging functionality
• Communication/interface functionality
• Mechanical integrity
• Record test results accurately and maintain traceability to the device/serial number.
• Identify, segregate, and report non-conforming products.
• Do not pass or release a device that does not meet specified acceptance criteria.

E. Packaging

• Perform final visual inspection before packaging.
• Ensure the device is clean and free from visible contamination, damage, loose components, or packaging defects.
• Pack the device and accessories according to approved packaging specifications.
• Verify correct inclusion of accessories, cables, manuals, labels, and other required components.
• Apply product labels, serial numbers, barcodes, and other identification labels correctly.
• Ensure packaging integrity and protection of the device during storage and transportation.
• Complete packaging and batch/production records as required.

F. Documentation and Traceability

• Complete production records, checklists, inspection records, and test reports accurately.
• Maintain traceability of components, assemblies, serial numbers, and production batches.
• Follow document-control requirements and use only current approved work instructions.
• Report deviations, defects, equipment issues, and process abnormalities to the supervisor.
• Support investigation of non-conformities and implementation of corrective actions.

G. Quality, Safety and Compliance

• Follow the company's Quality Management System and applicable medical-device manufacturing procedures.
• Maintain good housekeeping and workplace cleanliness.
• Follow ESD, electrical safety, chemical handling, PPE, and workplace safety requirements.
• Prevent mix-ups, contamination, component damage, and unauthorized process changes.
• Maintain confidentiality of product designs, manufacturing processes, and company information.

4. Required Skills and Competencies

• Basic knowledge of electronic and mechanical assembly.
• Practical soldering skills.
• Ability to read basic drawings, BOMs, assembly instructions, and work instructions.
• Ability to use basic hand tools, soldering equipment, measuring instruments, and test fixtures.
• Good visual inspection skills and attention to detail.
• Ability to identify common assembly and soldering defects.
• Basic computer and documentation skills.
• Ability to follow SOPs and standardized processes consistently.
• Strong focus on quality and traceability.
• Good hand-eye coordination and fine motor skills.
• Ability to work effectively as part of a production team.

5. Educational Qualification

Minimum: ITI / Diploma / equivalent technical qualification in Electronics, Electrical, Mechanical, Instrumentation, or a related field.
Candidates with relevant practical experience in electronics assembly, medical-device manufacturing, PCB assembly, soldering, testing, or packaging may also be considered.

6. Experience

Preferred: 1-3 years of experience in electronics, medical devices, diagnostic equipment, consumer electronics, or similar manufacturing environments.
Freshers with appropriate technical training and demonstrated soldering/assembly skills may also be considered.

7. Key Performance Indicators

• Assembly accuracy and first-pass yield
• Soldering quality and defect rate
• Functional testing pass rate
• Rework/rejection rate
• Packaging accuracy
• Production output
• Documentation and traceability accuracy
• Compliance with SOPs and work instructions
• Workplace safety and 5S compliance

8. Authority and Escalation

The Assembly Technician shall have the authority to stop the assembly/testing process and escalate any suspected product defect, component mismatch, abnormal test result, equipment malfunction, or process deviation to the Production Supervisor or Quality team.

9. Working Conditions
The position involves working in a controlled manufacturing environment and may require prolonged periods of standing/sitting, handling of small components, use of soldering equipment, and operation of electrical/electronic testing equipment. Appropriate PPE, ESD protection, ventilation, and safety procedures shall be followed as applicable.