Join the Future of Spinal Implant Innovation!
My client is seeking a Mechanical Design Engineer with expertise in Class III spinal implants to join their dynamic team.
As a leader in medical device development, they specialize in designing cutting-edge solutions that improve patients’ lives and set new industry standards.
If you have a passion for precision engineering and medical innovation, this is the opportunity for you!
Key Responsibilities :
- Design and develop Class III spinal implants , focusing on innovative, safe, and efficient solutions that meet regulatory requirements.
- Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to ensure products meet clinical and market needs.
- Perform FEA (Finite Element Analysis), CAD modeling, and tolerance analysis to optimize implant performance and reliability.
- Lead product testing and validation activities, ensuring compliance with ISO 13485 FDA , and other international standards.
- Develop detailed design documentation, including risk analyses, design reviews, and verification protocols.
- Support the transition of products from concept through to full-scale manufacturing
Requirements :
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- 5+ years of experience in mechanical design engineering, with a focus on Class III spinal implants or similar medical devices.
- In-depth knowledge of medical device design controls, including FDA Compliance and ISO 13485
- Proven ability to develop innovative design solutions while adhering to strict regulatory standards.
- Experience with materials commonly used in spinal implants.
- Strong communication skills to effectively collaborate with internal teams and external stakeholders.
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