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Medical Device Design Specialist
3 weeks ago
Job Overview
We are seeking a visionary Mechanical Architect to lead the development of innovative technologies that tackle complex healthcare challenges.
About the Role:
- 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.
Key Requirements:
- Bachelor's degree in Mechanical Engineering or related field.
- Proven experience in designing and developing medical devices.
- Excellent understanding of mechanical principles and medical device regulations.
- Strong communication and team collaboration skills.
- Ability to work under pressure and meet deadlines.
What We Offer:
- A competitive salary and benefits package.
- The opportunity to work on cutting-edge medical device projects.
- A collaborative and dynamic work environment.
- Ongoing training and professional development opportunities.
How to Apply:
Send your resume and cover letter to us at [insert email].