Senior Technical Architect – Mechanical Design - Medical Device @ Chennai

Company Description

Quest Global is a global engineering solutions company dedicated to solving the world's most challenging engineering problems. For over 25 years, we have been delivering end-to-end engineering solutions by leveraging deep industry knowledge and digital expertise. Headquartered in Singapore, Quest Global operates across 18 countries with 84 global delivery centers and a team of more than 21,000 professionals. We work across diverse industries, including aerospace, automotive, healthcare, medical devices, and more, to provide innovative solutions that address critical challenges effectively. As a trusted engineering partner, we are committed to building a brighter future and maintaining the highest standards of integrity throughout our business practices.

Role Description

This is a full-time hybrid role for a Senior Technical Architect – Mechanical Design - Medical Device located in Chennai, with some flexibility for remote work. The role involves leading and contributing to mechanical design projects, conducting maintenance and inspections, and utilizing advanced Computer-Aided Design (CAD) tools to create high-quality designs for medical devices. The architect will collaborate with cross-functional teams to ensure compliance with industry standards and contribute to innovative product development within the healthcare sector. Responsibilities also include mentoring team members, providing technical guidance, and ensuring the efficient execution of projects.

Key Responsibilities :

•       Mechanical Design

• Minimum

  8 years’ experience in medical devices, Renal dialysis machines and consumables design.

• Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)

• Develop Medical device architecture (Mechanical)

• Proficiency in Plastic, Sheetmetal and machined part design

• Design for compliance with regulatory standards

• Regulatory standards knowledge like IEC 60601-1, MDR 2017/745 or MDR 2017/746, QSR per 21 CFR Part 820, particular standards, collateral standards, FDA510K, UL, CE

• Provide key inputs to the team, take proactive initiatives and thorough knowledge on RCA/troubleshooting.

• Knowledge on Quality Management System as per ISO 13485

• Risk management documentation as per ISO 14971

• DFMEA, PFMEA and SFMEA document preparation and control

• Document and change management process in medical device industry using PDM/PLM software.

• Experience in Obsolescence management.

• Manage complete system Bill of materials.

• Should be cost conscious towards the device and should take up Value Engineering initiatives.

• Design documentation, review critical designs and release for Prototype/Production

• Prototype development and supplier management and detailed DFM reviews.

• Support for Pilot lot assembly & production support

• Support for maintenance of Design History file, Device History Record and Device Master Record documents

• Support for Verification and Validation tests (External and Internal)

• Proficiency in 3D tools like Solid works, Creo, etc.

• Concept Design and Complete Engineering design

• Good mechanical design skills with GD&T and tolerance stack up, FEA and CFD knowledge

• Good knowledge on manufacturing processes- DFM, DFA, DFT

• Material selection proficiency. Assess impact of alternate material and finalization with Supplier.

• Labelling and Packaging design experience

Work Experience

• Work experience with Mechanical part development/tool design, CAD drawings & Manufacturing Drawing
• Good Customer from ending, Delivery Leadership experience as Tech Architect, good Team player, Team management skills.
• Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing.
• Expertise in Change Management process.
• Experience in Sustenance activities in medical products/ Healthcare business
• Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR
• Ability to take initiatives and drive the project to completion