Job Summary

We are seeking a highly motivated Design Engineer with 5 to 8 years of experience in Medical Device Product Development. The ideal candidate will have strong expertise in Mechanical Product Design & Development, Design Controls, DFMEA, Risk Management, and Design Documentation. This role involves driving new product development activities while ensuring compliance with medical device regulations and quality standards.

Roles & Responsibilities

- Lead mechanical design and development activities for medical device products.
- Apply Medical Device Design Control processes throughout the product development lifecycle.
- Develop innovative concepts, detailed designs, and engineering solutions for new and existing products.
- Create and maintain design documentation including design inputs, design outputs, verification, validation, and design reviews.
- Conduct DFMEA (Design Failure Mode and Effects Analysis) and participate in risk assessment activities.
- Perform risk management activities in accordance with applicable regulatory requirements.
- Generate and maintain technical drawings, specifications, BOMs, and engineering documentation.
- Collaborate with cross-functional teams including R&D;, Quality, Regulatory Affairs, Manufacturing, and Supply Chain.
- Support design verification and validation testing activities.




- Drive design improvements, cost optimization, and product reliability initiatives.
- Ensure compliance with industry standards, quality systems, and regulatory requirements.

Technical Requirements

- Solid experience in Mechanical Product Design & Development.
- Hands-on experience with Medical Device Design Controls.
- Expertise in DFMEA and Risk Management methodologies.
- Experience in design documentation and engineering change management.
- Knowledge of product lifecycle management and design transfer processes.
- Strong understanding of manufacturing processes and engineering fundamentals.
- Excellent problem-solving, analytical, and communication skills.

Additional Responsibility

- Prior experience in the Medical Devices Industry.
- Familiarity with ISO 13485, ISO 14971, and FDA design control requirements.
- Exposure to design verification and validation processes.
- Knowledge of CAD tools such as SolidWorks or equivalent.
- Experience working in regulated product development environments.

Educational Requirement

MTech, Bachelor of Engineering, BE

Preferred Skills

- Technology - CAD - AutoCAD
- Technology - Embedded Software - Medical Devices

Service Line

Engineering Services

📌 Design Engineer (Medical Devices) (Pune)
🏢 Infosys
📍 Pune