Leading Medical Device Designer

Job Title: Mechanical Design Architect

You're a visionary Design Engineer driven by the passion to enhance patients' lives through groundbreaking medical devices. At our organization, your passion finds its purpose. Join us to design, develop, and test advanced mechanical systems for next-generation medical devices, working closely with a leadership team that brings over 100 years of collective experience and collaborates with premier research institutes.

As a Mechanical Design Architect in the medical device domain, you will lead the development of innovative technologies that tackle complex healthcare challenges. Your design engineering expertise will be pivotal in crafting and optimizing devices that uphold the highest standards of performance, safety, and regulatory compliance. Collaborating with cross-functional teams - including R&D, Quality Assurance, and Regulatory Affairs - you will play a key role in transforming visionary concepts into market-ready medical solutions.

Key Responsibilities:

• 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.
• Participate in continuous learning and development within the field of medical devices.

Required Skills and Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering from a reputable institution.
• A 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.