Innovative Design Engineer

We seek a visionary design engineer with an unwavering passion to revolutionize the medical device industry.

You will lead the development of innovative technologies that address complex healthcare challenges.

Collaborating with cross-functional teams, you will play a pivotal role in transforming groundbreaking concepts into market-ready medical solutions.

Key Responsibilities:

• Develop mechanical systems and sub-systems for medical devices from concept to production, driving innovation and precision.
• Design new products or components to meet specific performance, aesthetic, and functional requirements, prioritizing user experience.
• Create 3D models and detailed drawings using CAD software like Solidworks / Creo, pushing the boundaries of design excellence.
• Conduct engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize mechanical designs and ensure flawless function.
• Select appropriate materials based on factors like mechanical properties, thermal stability, biocompatibility, durability, sterilization compatibility, and cost-effectiveness, ensuring optimal performance.
• 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), staying ahead of industry trends.
• Stay up-to-date with the latest advancements in materials science, plastic technologies, and manufacturing processes, fostering continuous growth and improvement.
• 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, communicating effectively and efficiently.
• Ensure that all design and development activities adhere to relevant medical device regulations and standards, maintaining the highest level of integrity.
• Contribute to the development of new and innovative medical device technologies, driving the future of healthcare.

Requirements:

• Bachelor's or Master's degree in Mechanical Engineering from a reputable institution, emphasizing academic excellence.
• 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, applying mathematical rigor.
• Expertise in CAD software (e.g., SolidWorks, Creo, AutoCAD) and FEA simulation tools (e.g. ANSYS, COMSOL), leveraging technology to drive innovation.
• Experience with materials selection for medical devices, biocompatibility testing, and manufacturing processes for medical devices, ensuring optimal performance.
• Strong understanding of plastic component designs for medical devices, 3D printing and scanning of components for reverse engineering, staying ahead of industry trends.
• In-depth understanding of medical device regulations, standards, and certification processes, maintaining compliance and integrity.
• 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, thinking critically and creatively.
• Excellent interpersonal and communication skills to collaborate effectively with cross-functional teams, building strong relationships.
• Meticulous approach to design and documentation to ensure precision and regulatory compliance, delivering high-quality results.