Senior Manager, Development and Design Transfer at Natera

The role

The Senior Manager of Design Transfer leads the transition of next-generation sequencing assays from R&D into Operations under Quality Systems Regulations. This role manages a multidisciplinary team of scientists to ensure robust processes, regulatory compliance, and successful product launches.

What you'll do

• Lead and coordinate design transfer activities from R&D to manufacturing for NGS assays
• Manage a team of scientists providing technical mentorship and performance feedback
• Develop and execute detailed design transfer plans and process validations
• Lead test method development and characterization using statistical analysis and DOE
• Ensure compliance with FDA and ISO 13485 standards throughout the transfer process
• Partner with cross-functional teams to establish supply chains and ensure knowledge transfer

What you'll bring

• Advanced degree in molecular biology or a related scientific field
• At least six years of biotech industry experience with NGS technology
• Minimum of four years experience managing a team of scientists
• Proven track record of successful design transfer for medical devices
• Extensive knowledge of quality and regulatory standards including FDA and ISO

Your impact

You will ensure the seamless transition of complex diagnostic assays from development to production, directly enabling the delivery of high-quality genetic testing to patients. Your leadership in process validation and regulatory compliance will safeguard product integrity and support the company's mission to improve disease management worldwide.