Natera, Inc Design Transfer Manager in Austin

Natera, Inc. is hiring:
Design Transfer Manager in Austin Natera, Inc.
• Austin, TX, United States

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

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. The role will manage a multidisciplinary group of scientists, provide technical mentorship, and ensure timely delivery of project milestones.

The manager will also ensure robust processes, documentation, compliance with regulatory requirements, and cross‑functional alignment.

• Plan and manage activities and studies from late‑stage development to launch.
• Contribute to design documents such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partners.
• Participate in risk management activities (hazard analysis, FMEA) to identify hazards and propose controls to mitigate risks.
• 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; utilize 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.

• Manage a team of scientists to coordinate the execution of studies to support development of QC methods, verification studies and validation of assays.
• Provide leadership for scientists to ensure group effectiveness and development.
• Provide technical mentorship and decision‑making support for the team.
• Monitor performance, deliver timely feedback, and support career development of direct reports.
• Foster a culture of accountability, safety, compliance, and continuous learning.

• 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.

• 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 is 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…