
Medical Device Development Specialist
3 days ago
Job Opportunity:
">Seeking a skilled Medical Design Specialist to lead the development of cutting-edge medical devices. The ideal candidate will have expertise in design calculations, GD&T, and tolerance stack-up analysis.
">The successful candidate will be responsible for designing, developing, and testing advanced mechanical systems for next-generation medical devices. This includes conceptualizing, designing, developing, and optimizing mechanical systems and sub-systems from concept to production.
">Key Responsibilities:
">- ">
- 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, 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.">
- ">
- Bachelor's or Master's degree in Mechanical Engineering from a reputable institute.">
- Minimum of 8-12 years of prior experience in medical device design and development, with a strong understanding of regulatory requirements and standards.">
- 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 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.">
Benefits:
">- ">
- Opportunity to work on cutting-edge medical device projects.">
- Collaborative and dynamic work environment.">
- Professional growth and development opportunities.">
- Competitive compensation package.">
Others:
">- ">
- Must be able to work in a fast-paced environment and adapt to changing priorities.">
- Strong problem-solving, analytical, and communication skills.">
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