Product Development Engineer

Cure Talent are thrilled to be partnering with an innovative company who are at the forefront of developing Medical Devices.

We are looking for a Product Development Engineer where you will play a crucial role in ensuring the full traceability of the product development process working from initial requirements to final validation.

Responsibilities include:

• Play a key role in 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.

To be considered for this role you will need:

• Degree in Engineering (Electronics, Mechanical, or Manufacturing)
• A minimum of two years of experience in medical device development or a similarly regulated industry, with a track record of delivering innovative products to market.
• Familiarity with IEC 60601, ISO 13485, and ISO 14971 quality and risk management standards.
• Experience working with external suppliers, particularly overseas manufacturers.

If you’re eager to be at the forefront of medical device development and work with a company that prioritizes innovation, we’d love to hear from you!

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