Principal Medical Device Designer

We are seeking a visionary Mechanical Design Architect to drive the development of groundbreaking medical devices that enhance patients' lives.

The ideal candidate will lead the development of innovative technologies that tackle complex healthcare challenges. With expertise in design engineering, they will craft and optimize devices that uphold the highest standards of performance, safety, and regulatory compliance.

As part of our cross-functional team – including R&D, Quality Assurance, and Regulatory Affairs – you will play a key role in transforming visionary concepts into market-ready medical solutions.

• Conceptualize, design, develop, and optimize mechanical systems and sub-systems for medical devices from concept to production.
• Design new products or components to meet specific performance, aesthetic, and functional requirements.
• Create 3D models and detailed drawings using CAD software like Solidworks / CreO.
• Conduct engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure proper function.
• Select appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
• Develop and optimize products in sheet-metal, machining, and plastic processing techniques (e.g., injection molding, extrusion, blow molding, thermoforming, and other plastic processing techniques).
• Stay up-to-date with the latest advancements in materials science, plastic technologies, and manufacturing processes.
• Conduct rigorous testing and validation of designed systems to ensure functionality, performance, and compliance with relevant medical device standards (e.g., FDA, EUMDR, CDSCO, ISO 13485).
• Create and maintain accurate and comprehensive documentation of designs, specifications that includes interface design and specifications, test procedures, and verification reports for medical devices. Prepare progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
• Ensure that all design and development activities adhere to relevant medical device regulations and standards.
• Contribute to the development of new and innovative medical device technologies.

• Bachelor's or Master's degree in Mechanical Engineering from reputed Institute.
• Minimum of 8-12 years of prior experience in MEDICAL DEVICE design and development, with a strong understanding of regulatory requirements and standards.
• Strong skills in design calculations, GD & T, and tolerance stack-up analysis.
• Expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g., ANSYS, COMSOL).
• Experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.
• Strong understanding of plastic component designs for medical devices, 3D printing, and scanning of components for reverse engineering.
• In-depth understanding of medical device regulations, standards, and certification processes. Familiarity with FDA regulations (e.g., 21 CFR Part 820), ISO 13485 standards, CE marking requirements, and applicable international standards (e.g., IEC 60601).
• Strong analytical and problem-solving abilities to tackle complex design challenges.
• Excellent interpersonal and communication skills to collaborate effectively with cross-functional teams.
• Meticulous approach to design and documentation to ensure precision and regulatory compliance.

We offer a collaborative work environment where you can grow professionally and make a meaningful impact in the medical device industry. If you are passionate about delivering innovative solutions and committed to excellence, we would love to hear from you.