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Design Transfer Specialist
2 months ago
Cure Talent is seeking a highly skilled Design Transfer Lead to join a specialist agency providing design and development services for medical devices. This is an exciting opportunity for a seasoned professional to spearhead the transition of cutting-edge medical devices from design to full-scale manufacturing.
As the 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.
- Finalize Design History Files (DHF) and develop Device Master Records (DMR) for manufacturing handoff.
- 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.
Requirements:
- 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 manufacture (DFM).
What We're Looking For:
- A seasoned professional with a strong track record in design transfer and medical device manufacturing.
- Excellent communication and leadership skills, with the ability to manage cross-functional teams.
- A deep understanding of regulatory standards and compliance requirements.
- Experience in process validation and production scale-up.