R and D Engineer (Medical Devices) Jobs in Coimbatore Medical Device Company

📋 Job Description

Jobzi is sourcing qualified candidates for R and D Engineer (Medical Devices) positions in Coimbatore's private Medical Device Company sector. This is a full-time opportunity with a reputed Medical Device and Equipment employer in Coimbatore offering competitive salary, structured growth, and a professional work environment. Tamil communication skills are preferred alongside English for professional and business interaction in Coimbatore.

📌 Key Responsibilities

• Design and develop medical device components and sub-systems using CAD tools per design control requirements
• Build and test prototypes to evaluate form, fit, and functional performance against design inputs
• Conduct bench testing, verification, and validation activities and document results in design history files
• Apply design FMEA and risk analysis to identify and mitigate design-related failure modes
• Research materials for biocompatibility compliance per ISO 10993 and coordinate testing with labs
• Support design transfer activities to production including drawings, BOMs, and manufacturing specifications
• Collaborate with regulatory affairs on technical file documentation for device submissions

🎓 Qualifications and Requirements

• Which CAD tools have you used for medical device component or assembly design?
• Have you built prototypes and conducted bench testing for a medical device?
• Are you familiar with design controls and design history file requirements?
• Have you performed design FMEA or risk analysis for a medical device?
• What is your understanding of ISO 10993 biocompatibility testing requirements?
• Have you supported design transfer activities from R and D to production?
• Have you contributed to a regulatory technical file or design dossier?
• Good Tamil and English communication skills for team coordination and client interaction in Coimbatore.

✅ Required Skills

🏆 Certifications and Qualifications

B.E./B.Tech. (Biomedical, Mechanical, or Electronics) for engineering and field service roles; M.Sc. or B.Sc. in Life Sciences for IVD application and quality roles; ISO 13485 quality management system training; CDSCO MDR 2017 regulatory compliance knowledge for regulatory affairs roles; IEC 60601 and CE marking awareness for quality roles; Lean Manufacturing and GMP training for production roles; BLS and medical device demonstration certification for clinical sales specialists