Mechanical Technical Lead – Medical Devices

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.

• 
  Mechanical Design Engineer with 8-12 Years of experience
• Minimum 6 years’ experience in medical devices industry, Renal dialysis machines and consumables design.
• Hands on experience in all phases of medical device life cycle (NPD, sustenance, post market support)
• Experience in leading a team of mechanical engineers in the medical device industry, providing guidance, mentorship, and technical expertise
• Excellent communication skills to effectively communicate with internal and external stakeholders, presenting technical information clearly and concisely
• Experience in conducting design reviews, design verification, and validation activities to ensure compliance with regulatory requirements and industry standards
• Knowledge of international regulations and standards related to medical devices, ensuring products meet global market requirements
• Continuous improvement mindset, identifying opportunities to enhance design processes, reduce costs, and improve product performance
• Ability to adapt to changing priorities and work in a fast-paced, dynamic environment while maintaining attention to detail and quality standards
• Passion for innovation and staying updated on emerging technologies and trends in the medical device industry
• Ability to collaborate with cross-functional teams including R&D, Quality, Regulatory, and Manufacturing to ensure successful product development and launch
• Develop Medical device architecture (Mechanical)
• Design for compliance with regulatory standards
• Design Control documentation for Renal care disposables products
• Risk management documentation as per ISO 14971
• DFMEA, PFMEA and SFMEA document preparation and control
• Prototype development and supplier management and detailed DFM reviews.
• Support for Verification and Validation tests
• Proficiency in 3D tools like Solid works, Creo, etc.
• Proficiency in GD&T and tolerance stack up

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, CAD drawings & Manufacturing Drawing.
• 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.
• Lead team effectively and work closely with customers. Project scheduling and planning.

Desired Skills:

• Experience in medical devices industry is mandatory, Renal dialysis machines and consumables design
• Knowledge of 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.
• Strong communication skills to effectively collaborate with cross-functional teams and external stakeholders in the medical devices industry.