Senior Product Development Engineer

Cure Talent are thrilled to partner with a global leader in the orthopaedic medical device industry to recruit a Senior Product Development Engineer. This is a fantastic opportunity to join an innovative company at the forefront of developing cutting-edge orthopaedic solutions that make a real difference in patients’ lives.

As the new Senior Development Engineer, you will play a pivotal role in the innovation and evolution of orthopaedic medical devices. You will take ownership of projects from initial concept through to commercial launch, ensuring that designs meet clinical, regulatory, and manufacturing requirements. Your expertise will drive the development of technical solutions that enhance product performance and patient outcomes.

Key Responsibilities:

• Lead the development of new medical devices, from concept to commercial launch, ensuring compliance with regulatory standards.
• Create and maintain technical documentation, including design history files, risk management files, and technical files.
• Conduct design verification and validation activities, managing external test vendors and ensuring robust device functionality.
• Collaborate with subcontract manufacturers to implement design for manufacture and assembly, supporting smooth design transfer.
• Provide technical expertise for regulatory submissions, QMS compliance audits, and remediation of legacy products.

Requirements:

• A degree in engineering or a related technical field with a minimum of 5 years’ experience in medical device design and development.
• Proficiency in 3D CAD modelling and engineering drawings; experience with Siemens NX is highly desirable.
• In-depth knowledge of ISO 13485, 21 CFR 820, and ISO 14971 quality and risk management standards.
• Familiarity with manufacturing processes for medical devices. (Orthopaedic devices and an understanding of skeletal anatomy and biomaterials is advantageous)
• A proactive and driven individual with the ability to manage multiple projects in a fast-paced environment.

If you’re a skilled engineer looking to work at the cutting edge of medical device innovation, we’d love to hear from you!