Associate Mechanical Design Engineer - Medical Devices

<strong>Job Requirements </strong><br><p><strong>Associate Mechanical Design Engineer – Medical Devices</strong></p><p><strong>About Quest Global</strong></p><p>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.</p><p><strong>Role Overview</strong></p><p>We are seeking a passionate and driven <strong>Associate Mechanical Design Engineer</strong> to join our Medical Devices team. In this role, you will assist in the design, development, and sustenance of life-changing medical equipment, specifically focusing on <strong>renal dialysis machines and consumables</strong>. This is an excellent opportunity for an early-career engineer to grow their skills in a highly regulated, fast-paced environment while working alongside industry experts.</p><p><strong>Qualifications & Experience</strong></p><ul><li><strong>Experience:</strong> <strong>3–6 years</strong> of experience in mechanical design engineering.</li><li><strong>Industry Focus:</strong> Minimum <strong>2 year of experience in the medical devices industry</strong>, with exposure to renal dialysis machines or medical consumables design highly preferred.</li><li><strong>Core Skills:</strong> Proficiency in <strong>3D CAD tools (SolidWorks, Creo, etc.)</strong> along with a foundational understanding of <strong>GD&T and basic tolerance stack-up analysis</strong>.</li><li><strong>Communication:</strong> Strong communication skills to effectively collaborate with internal teams and present technical data clearly.</li><li><strong>Adaptability:</strong> Ability to adapt to changing priorities in a dynamic, fast-paced environment while maintaining an absolute focus on quality and attention to detail.</li><li><strong>Mindset:</strong> A continuous learning mindset, a passion for innovation, and a desire to stay updated on emerging technologies in healthcare engineering.</li></ul><p><strong>Key Responsibilities</strong></p><ul><li><strong>Design Support:</strong> Assist in the mechanical design and modification of medical device sub-assemblies and renal care disposable products under the guidance of senior engineers.</li><li><strong>CAD & Documentation:</strong> Create accurate 3D models, detailed 2D production drawings, and maintain precise <strong>Design Control documentation</strong> in compliance with regulatory standards.</li><li><strong>Risk & Quality Management:</strong> Participate in risk assessment sessions and support the preparation of <strong>DFMEA, PFMEA, and SFMEA</strong> documents as per <strong>ISO 14971</strong>.</li><li><strong>Prototyping & DFM:</strong> Support prototype development, participate in detailed <strong>Design for Manufacturing (DFM)</strong> reviews, and assist with supplier coordination.</li><li><strong>Verification & Validation:</strong> Assist in conducting design verification and validation (V&V) testing, compiling test data, and documenting results to ensure compliance with global regulatory frameworks.</li><li><strong>Cross-Functional Collaboration:</strong> Coordinate with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to support successful product development and post-market sustenance.</li></ul><p><strong>Our Culture</strong></p><p>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.</p><p><strong>Experience Level</strong></p><p>4–6 years</p><p><strong>Assists and supports</strong> design sub-assemblies under guidance</p><p><strong>Leadership </strong>Conducts design reviews and manages suppliers</p><p><strong>Participates</strong> in reviews; supports supplier coordination</p><p><strong>Risk Documentation </strong>controls DFMEA/PFMEA/SFMEA</p><p><strong>Assists in the preparation</strong> and data compilation for FMEAs</p><p><strong>Foundational knowledge</strong> of GD&T and basic stack-ups</p><br><br><strong>Work Experience </strong><br><p><strong>Work Experience</strong></p><ul><li>Work experience with Mechanical part development, CAD drawings & Manufacturing Drawing.</li><li>Proficiency in Carrying out Tests – Functional test, Critical IEC tests & Particular standards testing.</li><li>Expertise in Change Management process. Experience in Sustenance activities in medical products/ Healthcare business.</li><li>Good knowledge on ISO 13485 QMS, IEC Standards (General Safety, Particular & Collateral) and MDR.</li><li>Ability to take initiatives and drive the project to completion.</li><li>Lead team effectively and work closely with customers. Project scheduling and planning.</li></ul><p> </p><p><strong>Desired Skills:</strong></p><ul><li>Experience in medical devices industry is mandatory, <strong>Renal dialysis machines and consumables design</strong></li><li>Knowledge of Product Life Cycle management and Supplier transfer activities for Mechanical components.</li><li>Ability to support engineers by providing new or alternative design solutions and contribute to product development decisions.</li><li>Proficient use of enabling technology, computer, and time management skills.</li><li>Strong communication skills to effectively collaborate with cross-functional teams and external stakeholders in the medical devices industry.</li></ul><br><br>