Design Transfer Manager

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. The role will be managing a multidisciplinary group of scientists, providing technical mentorship, and ensuring timely delivery of project milestones. The manager also will ensure robust processes, documentation, compliance with regulatory requirements, and cross-functional alignment. PRIMARY RESPONSIBILITIES:Design Transfer LeadershipResponsible for planning and managing activities and studies from late-stage development to launchContribute to design documents, such as reagent stability plans, design inputs, design outputs, design verification protocols and reports while working closely with Quality and Regulatory partnersRoutinely participate in risk management activities (such as hazard analysis, FMEA) to identify hazards and its causes and propose controls to mitigate risksWorks closely with bioinformatics / statistics groups in aligning with rationale for study designs and acceptance criteriaDevelop and execute detailed design transfer plansLead and coordinate design transfer activities from R&D to manufacturingLead test method development, characterization, and validationConduct studies to generate specifications and set process/test method specifications based on statistical analysisLead process validations; experience with single-site oncology assay validations is requiredAssure experimental quality through sound experimental design; utilize DOE, Cpk analysis, and Gage R&R, and mentor others in study designLead cross-functional efforts to establish supply chain for raw materials and consumables; propose and implement improvementsEnsure compliance with FDA, ISO 13485, and quality system regulations during design transfer and productionCommunicates progress directly with colleagues and senior managementTeam & People ManagementManages a team of scientists to coordinate the execution of studies to support development of QC methods, verification studies and validation of assaysManage and provide leadership for scientists to ensure group effectiveness and developmentProvide technical mentorship and decision-making support for the teamMonitor performance, deliver timely feedback, and support career development of direct reportsFoster a culture of accountability, safety, compliance, and continuous learningCross-Functional CollaborationPartner with Operations, R&D, Product Management, Quality Assurance, and Regulatory Affairs to ensure seamless design transfer and product launchServe as the primary liaison between development and operations, ensuring knowledge transfer and training of operational staffIncorporate operational feedback into design improvements and refinementsContribute technical and process documentation to regulatory submissionsActively participate in the project core team and program team meetings, provide project updates to cross functional teams and senior leadershipDocumentation & ComplianceOversee creation, review, and approval of SOPs, work instructions, and verification/validation protocols and reportsEnsure compliance with FDA, ISO, CLSI, and other international regulatory requirements, including GLP/GMPMaintain audit-ready documentation for internal and external inspectionsQUALIFICATIONS:Advanced degree in molecular biology or related discipline. PhD is preferred; Master's or bachelor's with equivalent industry experience considered6-8 years of post-PhD biotech industry experience or >10 years of post BS/MS biotech experienceAt least 4 years managing a team of scientists and research associatesKNOWLEDGE, SKILLS, AND ABILITIES:Must have hands-on experience with next-generation sequencing (NGS) and DNA/RNA molecular biologyKnowledge of methylation-based technologies and their IVD application is highly desirableProven track record of successful design transfer for assays and medical devicesStrong understanding of assay development, design control, analytical validation, and manufacturing workflowsExtensive knowledge of quality and regulatory standards (ISO, CLSI, FDA)Ability to establish and follow SOPs, with in-depth knowledge of GLP/GMP guidelinesExperience authoring study plans, protocols, and study reports is highly desirableExperience with process validations for single-site oncology assaysProficiency in experimental design, statistical data analysis, and technical problem-solvingDemonstrated ability to lead multidisciplinary teams and provide mentorship to research associates and junior scientistsStrong project management and organizational skillsExcellent communication and presentation abilities, including reporting to senior leadershipCollaborative, adaptable, and focused on achieving business and corporate objectivesOUR OPPORTUNITYNatera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.WHAT WE OFFERCompetitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral programFor more information, visit Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws.If you are based in California, we encourage you to read this important information for California residents.Link: Please be advised that Natera will reach out to candidates with a email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.For more information: BBB announcement on job scamsFBI Cyber Crime resource page