Senior Manager, Development and Design Transfer

About the role

POSITION SUMMARY: We are seeking an experienced Senior Manager, Design Transfer to lead and coordinate the transfer of products 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 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, design verification protocols and reports while working closely with Quality and Regulatory partners Routinely participate in risk management activities (such as hazard analysis, FMEA) to identify hazards and its causes and propose controls to mitigate risks Works closely with bioinformatics / statistics groups in…

This is a summary of the advert. The full description and the application are on Natera's careers site.

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