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Design Transfer Lead
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. As a key member of the team, you will be responsible for overseeing the smooth transition of cutting-edge medical devices from design to full-scale manufacturing.
Key Responsibilities:
- Lead Design Transfer: Ensure seamless transition from development to production while meeting regulatory standards.
- Finalize Design History Files (DHF) and Develop Device Master Records (DMR): Prepare and finalize critical documentation for manufacturing handoff.
- Manage Supplier Qualification: Conduct audits and ensure compliance with ISO 13485 and MDR standards.
- Oversee Process Validation: Ensure consistent high-quality manufacturing output through rigorous testing and validation.
- Collaborate with Cross-Functional Teams: Align the design transfer process with R&D, QA, and Regulatory Affairs teams.
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:
- Highly skilled professionals with experience in design transfer, product development, and new product introduction.
- Strong leadership and project management skills, with the ability to manage cross-functional teams.
- Excellent communication and problem-solving skills, with a focus on delivering high-quality results.
