Senior Scientist, R&D Design Transfer & Product Development

POSITION SUMMARY: The Senior Design Transfer Scientist will lead and support the transition of In Vitro Diagnostic (IVD) Next-Generation Sequencing (NGS) assays from R&D to Operations. This role is responsible for planning, executing, and documenting all design transfer activities while ensuring strict compliance with regulatory and quality standards. The ideal candidate will balance hands-on laboratory work, data analysis, and documentation. As a cross-functional collaborator, you will interface with multiple functional groups to drive project deliverables to completion in a dynamic, fast-paced environment. PRIMARY RESPONSIBILITIES: Design Transfer & Validation: Plan and execute process validations (IQ/OQ/PQ), stability studies, and study protocols; perform data analysis and author final reports Test Method Development: Support test method development, characterization, and Test Method Validation (TMV), including the generation of manufacturing specifications Quality & Risk Management: Lead Risk Management activities (including FMEAs) to identify and mitigate product risks; establish and maintain Design History Files (DHF) and Device Master Records (DMR) Sustaining & Change Control: Lead change control activities to evaluate and determine the impact of design changes to on-market products CAPA & Troubleshooting: Investigate product or process deviations, perform root cause an...