Senior Technical Architect – Medical Devices

Job Requirements

At Quest Global, it's not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

• Key Responsibilities
• Mechanical Design Engineer with 15-20 Years of experience
• 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 , 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

We are known for our extraordinary people who make the impossible possible every day. Questians are driven by hunger, humility, and aspiration. We believe that our company culture is the key to our ability to make a true difference in every industry we reach. Our teams regularly invest time and dedicated effort into internal culture work, ensuring that all voices are heard.

We wholeheartedly believe in the diversity of thought that comes with fostering a culture rooted in respect, where everyone belongs, is valued, and feels inspired to share their ideas. We know embracing our unique differences makes us better, and that solving the worlds hardest engineering problems requires diverse ideas, perspectives, and backgrounds. We shine the brightest when we tap into the many dimensions that thrive across over 21,000 difference-makers in our workplace.

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.

Desired Skills:

• Knowledge in Product Life Cycle management and Supplier transfer activities for Mechanical components
• Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions.
• Proficient use of enabling technology, computer and time management skills.
• Having Japanese Visa and willing to work on short term/long time onsite assignment will be added advantage.