Design Transfer Manager

Sr. Technical Recruiter - Data, R&D, and Technology at Natera

POSITION LOCATION: We are considering candidates for either our Austin, TX or San Carlos, CA locations.

Position Summary: We are seeking an experienced Design Transfer Manager to lead and coordinate the transfer of an early cancer detection assay from R&D into Operations. This role will plan, execute, implement, and document all design transfer activities for a next‑generation sequencing (NGS) IVD/PMA assay under Quality Systems Regulations and Design Control. It will manage a multidisciplinary group of scientists, provide technical mentorship, and ensure timely delivery of project milestones, while maintaining robust processes, documentation, regulatory compliance, and cross‑functional alignment.

• Design Transfer Leadership
  • Responsible for planning and managing activities and studies from late‑stage development to launch.
  • Contribute to design documents, such as reagent stability plans, design inputs, design outputs, and verification protocols while working closely with Quality and Regulatory partners.
  • Participate in risk management activities (e.g., hazard analysis, FMEA) to identify hazards and propose controls.
  • Work closely with bioinformatics/statistics groups to align study designs and acceptance criteria.
  • Develop and execute detailed design transfer plans.
  • Lead and coordinate design transfer activities from R&D to manufacturing.
  • Lead test method development, characterization, and validation.
  • Conduct studies to generate specifications and set process/test method specifications based on statistical analysis.
  • Lead process validations; experience with single‑site oncology assay validations is required.
  • Assure experimental quality through sound experimental design, utilizing DOE, Cpk analysis, and Gage R&R, and mentor others in study design.
  • Lead cross‑functional efforts to establish supply chain for raw materials and consumables; propose and implement improvements.
  • Ensure compliance with FDA, ISO 13485, and quality system regulations during design transfer and production.
  • Communicate progress directly with colleagues and senior management.
• Team & People Management
  • Manage a team of scientists to coordinate the execution of studies supporting QC method development, verification, and assay validation.
  • Provide leadership to ensure group effectiveness and development.
  • Offer technical mentorship and decision‑making support.
  • Monitor performance, deliver timely feedback, and support career development of direct reports.
  • Foster a culture of accountability, safety, compliance, and continuous learning.
• Cross‑Functional Collaboration
  • Partner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product launch.
  • Serve as the primary liaison between development and operations, ensuring knowledge transfer and training of operational staff.
  • Incorporate operational feedback into design improvements and refinements.
  • Contribute technical and process documentation to regulatory submissions.
  • Actively participate in the project core team and program team meetings, providing project updates to cross‑functional teams and senior leadership.
• Documentation & Compliance
  • Oversee creation, review, and approval of SOPs, work instructions, and verification/validation protocols and reports.
  • Ensure compliance with FDA, ISO, CLSI, and other international regulatory requirements, including GLP/GMP.
  • Maintain audit‑ready documentation for internal and external inspections.

• Advanced degree in molecular biology or related discipline. PhD preferred;
  Master’s or bachelor's with equivalent industry experience considered.
• 6‑8 years of post‑PhD biotech industry experience or >10 years of post‑BS/MS biotech experience.
• At least 4 years managing a team of scientists and research associates.

• Hands‑on experience with next‑generation sequencing (NGS) and DNA/RNA molecular biology.
• Knowledge of methylation‑based technologies and their IVD application is highly desirable.
• Proven track record of successful design transfer for assays and medical devices.
• Strong understanding of…