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Senior Scientist, R&D Design Transfer & Product Development
Natera San Carlos, CA Posted Sep 8
About the role
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.
What you'll do
- 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 analysis, and implement Corrective and Preventive Actions (CAPA)
- Cross-Functional Collaboration: Partner with Supply Chain to establish raw material and consumable pipelines; present status updates, data, and technical proposals to cross-functional stakeholders
What you'll need
Natera lists the full requirements on its posting.