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.