Medical Device Design engineer

Medical Device Design Engineer

Location: Chennai, Tamil Nadu, India Job Type: Full-Time

The position is for a dynamic and innovative Engineering Design firm committed to improving design outcomes through cutting-edge device design. This position is for a design and R&D hub in Chennai, focused on developing next-generation Engineering devices. We seek a passionate and experienced engineer to drive core technical design and execution for our critical projects.

The Role: Senior Medical Device Design Engineer

We are looking for a highly skilled and motivated Medical Device Design Engineer to manage and execute the complete product development lifecycle for assigned sub-systems, from concept generation through to production release. This role requires deep technical expertise in mechanical or electromechanical design and strong proficiency in collaborating effectively with quality, regulatory, and manufacturing departments to ensure technical success.

Key ResponsibilitiesTechnical Design & Development

• Drive the design, development, and testing of complex medical device sub-systems and components (e.g., surgical instruments, monitoring systems, implants) in accordance with user needs and design inputs.
• Perform advanced mechanical analysis, material selection, tolerance stack-up analysis, and DFM (Design for Manufacturing) / DFA (Design for Assembly) assessments.
• Develop detailed engineering drawings, specifications, and comprehensive test protocols.
• Drive continuous improvement and innovation by researching new technologies, materials, and manufacturing processes relevant to medical technology.

Project Execution & Collaboration

• Contribute significantly to the planning, tracking, and execution of design verification and validation activities, ensuring technical tasks and project milestones are met on time.
• Coordinate proactively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Manufacturing Engineering, across local and global sites.
• Act as the key technical resource for manufacturing transfer and troubleshooting activities.

Quality & Regulatory Compliance

• Ensure all design control activities comply with regulatory standards, including ISO 13485, FDA 21 CFR Part 820 (Design Controls), IEC 60601 (if applicable), and CE Mark requirements.
• Author, review, and maintain comprehensive Design History File (DHF) documentation, including risk management (ISO 14971) and essential performance requirements.
• Participate actively in technical design reviews (PDR, CDR) and ensure adherence to established internal quality procedures.

Required Qualifications

• Education: Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a closely related field.
• Experience: Minimum of 5+ years of experience in the design and development of commercial medical devices (Class I, II, or III).
• Design Tools: High proficiency in 3D CAD software (e.g., SolidWorks, Creo, or equivalent) and finite element analysis (FEA).
• Medical Domain: Strong understanding of medical device materials, sterilization processes, and biocompatibility requirements.
• Regulatory Knowledge: Deep working knowledge of Design Controls (FDA 21 CFR 820) and Risk Management (ISO 14971).

Preferred Qualifications

• Experience with plastic injection molding, tooling design, and high-volume manufacturing processes relevant to the Indian market.
• Familiarity with the Indian medical device regulatory landscape (CDSCO).
• Six Sigma or Lean Design certification.
• Experience integrating electronics and software into electromechanical medical devices.
• Experience with rapid prototyping technologies (e.g., 3D printing).

Job Type: Full-time

Pay: ₹150,000.00 - ₹200,000.00 per month

Work Location: In person