Production Engineer Radiology

Job Title: Production Engineer - Equipment Assembly (Radiology & Imaging Systems) Department: Production / Manufacturing - Radiology Division Location: Vapi, Gujarat Reports To: Production Supervisor / Production Manager - Radiology Systems Job Purpose: To perform and supervise cable connections, fitting, and assembly operations for high-precision radiology and imaging systems such as X-Ray, C-Arm, CT scan, DR system units, ensuring that all production activities meet stringent quality, safety, and performance standards. Key Responsibilities: 1. Assembly and Wiring Operations - Execute electrical wiring, cable routing, crimping, and harness assembly for radiology and imaging equipment. - Perform mechanical fitting and sub-assembly of modules including X-ray tubes, detectors, high-voltage generators, and gantry systems. - Ensure accurate integration of electrical, electronic, and mechanical components as per engineering drawings and assembly instructions. - Conduct preliminary alignment and connection checks prior to system integration and testing. 2. Quality and Compliance - Adhere strictly to SOPs, assembly checklists, and work instructions throughout the production process. - Perform in-process quality inspections and promptly identify electrical cable connections and mechanical defects. - Ensure compliance with ISO 13485, GMP, IEC safety standards, and ESD handling protocols. - Maintain cleanliness, organization, and visual management standards in accordance with 5S and Lean Manufacturing principles. 3. Coordination and Technical Support - Collaborate with Design, Quality, and Testing teams to resolve assembly or electrical cable connection issues. - Support the testing, calibration, and validation of imaging systems during production trials. - Provide technical feedback to enhance assembly methods, tooling efficiency, and product reliability. - Assist in new product introduction (NPI) by supporting prototype and pilot builds. 4. Documentation and Reporting - Maintain accurate production logs, assembly records, and material usage reports. - Record non-conformities, assist in root cause analysis, and contribute to corrective and preventive actions (CAPA). - Ensure full traceability of critical components and maintain documentation for audits and regulatory compliance. Qualifications and Experience: - Diploma / B.E. / B.Tech in Electrical, Electronics, Mechanical, Mechatronics, or Biomedical Engineering. - 3-5 years or more of experience in assembly and electrical cable connection of medical imaging or electro-mechanical equipment. - Hands-on experience in high-voltage wiring, PCB interfacing, harness assembly, and mechanical integration. - Prior experience in X-Ray, C-Arm, CT systems, or other diagnostic imaging equipment will be highly preferred. - Familiarity with CE and IEC safety compliance requirements for medical devices. Skills and Competencies: - Strong practical skills in electrical wiring, assembly, and mechanical fitting. - Ability to read and interpret electrical schematics, electrical wiring diagrams, and mechanical layouts. - Understanding of high-voltage systems, grounding, and shielding techniques used in imaging devices. - Attention to detail, precision, and adherence to process discipline. - Effective troubleshooting and problem-solving skills. - Good communication, teamwork, and documentation abilities. Key Performance Indicators (KPIs): - Accuracy and quality of system assembly and wiring - On-time completion of production schedules - Reduction in rework, rejections, and downtime - Compliance with quality and safety standards - Implementation of process improvement initiatives