Medical Product Development Specialist

Job Title: Medical Product Development Specialist

We are seeking an innovative Design Engineer who is passionate about creating life-changing medical devices. In this role, you will have the opportunity to work on cutting-edge technologies that tackle complex healthcare challenges.

As a Medical Product Development Specialist, you will lead the development of innovative medical products that meet the highest standards of performance, safety, and regulatory compliance. Your design engineering expertise will be pivotal in crafting and optimizing devices that transform patients' lives.

Key Responsibilities:

• Conceptualize, design, develop, and optimize medical systems and sub-systems 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.
• Conducting engineering analyses, including stress, thermal, and fluid dynamics simulations, to optimize medical 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.
• Conducting 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).
• Creating and maintaining accurate and comprehensive documentation of designs, specifications, interface design and specifications, test procedures, and verification reports for medical devices. Preparing progress reports, technical presentations, and updates for project stakeholders, regulatory submissions, and audits.
• Ensuring that all design and development activities adhere to relevant medical device regulations and standards.
• Contributing to the development of new and innovative medical device technologies.
• Participating in continuous learning and development within the field of medical devices.

Requirements:

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