Design Transfer Lead

Cure Talent are thrilled to partner with a specialist agency providing design and development services for medical devices. Due to increasing demand and ongoing major projects, we are looking for a Design Transfer Lead to join their dynamic team and spearhead the transition of cutting-edge medical devices from design to full-scale manufacturing.

As the new Design Transfer Lead, you will be responsible for overseeing the smooth transition of products from development to production, ensuring compliance with ISO 13485, ISO 14971, and MDR standards. You will have a robust understanding of medical device design transfer processes, with proven experience in managing cross-functional teams through this critical phase.

Key Responsibilities:

• Lead design transfer, ensuring smooth transition from development to production while meeting regulatory standards.
• Finalise Design History Files (DHF) and develop Device Master Records (DMR) for manufacturing.
• Manage supplier qualification, conducting audits and ensuring compliance with ISO 13485 and MDR.
• Oversee process validation to ensure consistent high-quality manufacturing output.
• Collaborate with cross-functional teams, including R&D, QA, and Regulatory Affairs, to align the design transfer process.

Skills and Experience

• Proven experience in medical device design and manufacturing transfer.
• Strong knowledge of ISO 13485, ISO 14971, and MDR compliance.
• Experience in supplier qualification, audits, and manufacturing readiness.
• Expertise in process validation (IQ, OQ, PQ) and production scale-up.
• Leadership in risk management, project management, and design for manufacturability (DFM).

If you’ve worked on Design Transfer, Product Development, New Product Introduction, or have Project Managed the development and transfer of medical products into manufacturing, we would love to hear from you!