Mechanical Engineer

Mechanical Design Engineer

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.

Roles & Responsibilities:

• Mechanical Design Engineer with 6-10 years of experience
• Minimum 3-5 years' experience in the medical device industry
• Hands-on experience in all phases of the medical device life cycle (NPD, sustenance)
• 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, etc.
• 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 the medical device industry using PDM/PLM software
• Experience in obsolescence management
• Manage complete system Bill of materials
• 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
• 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
• Good knowledge of manufacturing processes
• Material selection proficiency. Assess the impact of alternate material and finalization with Supplier
• Labelling and Packaging design experience

Required Skills (Technical Competency):

• Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing
• Experience in Sustenance activities in medical products/ Healthcare business
• Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing
• Expertise in Change Management process
• Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR
• Ability to take initiatives and drive the project to completion
• Lead team effectively and work closely with customers

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 world’s 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.