Master Medical Device Designer

We are seeking a skilled Mechanical Design Architect to join our team. This role will involve conceptualizing, designing, developing, and optimizing mechanical systems and sub-systems for medical devices from concept to production.

The ideal candidate will have expertise in CAD software (e.g., SolidWorks, CreO, AutoCAD) and FEA simulation tools (e.g. ANSYS, COMSOL). They should also have experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices.

As a Mechanical Design Architect, you will lead the development of innovative technologies that tackle complex healthcare challenges. Your expertise in designing and optimizing devices will be pivotal in crafting products that uphold the highest standards of performance, safety, and regulatory compliance.

Key responsibilities include:

• Conceptualize, design, develop, and optimize mechanical systems and sub-systems for medical devices from concept to production.
• Designing new products or components to meet specific performance, aesthetic, and functional requirements.
• Creating 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.
• Selecting appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness.
• Developing and optimizing products in sheet-metal, machining and plastic processing techniques (e.g. injection molding, extrusion, blow molding, thermoforming, and other plastic processing techniques).
• Staying 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.
• Participate in continuous learning and development within the field of medical devices.

To excel in this role, you should possess the following qualifications:

• 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.
• Strong problem-solving, analytical, and communication skills.

At our company, we prioritize innovation, teamwork, and customer satisfaction. We believe that our employees are the key to our success and offer opportunities for professional growth, skill development, and recognition. Our team is dedicated to delivering high-quality products and services that exceed customer expectations.