Onsite & Floor Assembly Technician

Job Requirements

Job Description: Onsite & Floor Assembly Technician:

We are seeking a detail-oriented and technically skilled Assembly & Testing Engineer Mobile C-Arm Manufacturing to join our team. In this role, you will be responsible for the mechanical and electrical assembly, integration, alignment, calibration, and testing of mobile C-arm imaging systems used in surgical and diagnostic procedures. The successful candidate will ensure that products are assembled and tested in accordance with engineering specifications, quality standards, regulatory requirements, and safety guidelines. The ideal candidate will have hands-on experience with electromechanical systems, a strong understanding of manufacturing and quality processes, and a commitment to delivering high-quality medical devices. Strong English communication skills and the ability to work effectively in cross-functional and multicultural teams are essential for success in this role.

Activities & Responsibility:

1. Manufacture Mobile C-Arm systems in accordance with the production plan and forecast while meeting quality, delivery, and productivity targets.

2. Perform qualified assembly, integration, and testing activities, including mechanical, electrical, electronic, and electromechanical assemblies and sub-assemblies, in compliance with approved work instructions and manufacturing procedures.

3. Continuously monitor the availability of parts, tools, equipment, and test resources required to ensure uninterrupted production flow and timely completion of manufacturing activities.

4. Execute all manufacturing and testing activities in compliance with applicable regulations, quality standards, and safety requirements, including ESD control, radiation protection, and workplace safety guidelines.

5. Operate specialized manufacturing and test equipment, tools, and fixtures, while ensuring their proper use, functionality, and maintenance.

6. Create, review, and maintain accurate Device History Records (DHR) and manufacturing documentation for each Mobile C-Arm system in accordance with regulatory and quality requirements.

7. Investigate and resolve issues identified during assembly and testing, support root cause analysis activities, and implement corrective and preventive actions in collaboration with cross-functional teams.

8. Actively contributes to continuous improvement initiatives focused on product quality, manufacturing efficiency, process optimization, cost reduction, and operational excellence.

9. Support Process Engineering and Process Planning teams in process verification, validation, qualification, and implementation of new products, tools, and manufacturing processes.

10. Ensure adherence to Good Manufacturing Practices (GMP), company quality management system requirements, and relevant medical device regulatory standards. 11. Participate in training, knowledge-sharing, and skill development activities to continuously enhance technical competencies and manufacturing capabilities.

Qualification:

The successful candidate shall possess the following qualifications, skills, and experience:

1. Diploma in Electronics or Electrical or Mechanical Engineering

2. 1-2 years of hands-on experience in the assembly, integration, and testing of medical devices, preferably Mobile C-Arm, X-ray, or other medical imaging systems

3. Basic know-how of X-ray technology is preferable.

4. Familiarity with applicable medical device standards and quality systems, including IEC 60601-1, ISO 9001, ISO 13485, and other relevant regulatory requirements.

5. Knowledge of radiation safety, health protection requirements, electrical safety, and Electrostatic Discharge (ESD) control practices.

6. Understanding of Lean Manufacturing, Continuous Improvement methodologies, 5S principles, and problem-solving techniques.

7. Good verbal and written English communication skills and the ability to work effectively in cross-functional and multicultural teams.

8. Self-motivated, quality-focused, and committed to maintaining high standards of safety, compliance, and operational excellence.