Job Description

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 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 protoco...

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