Job Description

The Senior Scientist , R&D Operations is responsible for on-market product support in terms of post-market activities, to evaluate the performance of products against country-specific requirements and documentation for registration that drive significant impact to the organization.

This position is part of the R&D, Global Market Protection group and is in Sunnyvale, CA.

Shift : M-F, Standard Working Hours

Pay : $55-$60/hr

1 year contract role with strong potential for extension or conversion

Responsibilities :

• Solve complex problems and work in a cross-functional team-based environment.
• Work collaboratively as part of a team while also working independently to produce data and meet challenging timelines and goals.
• Research, initiate and procure clinical specimens and clinical matrices for R&D projects and execute end-to-end testing until final report generation.
• Gain hands-on experiences in molecular point of care tests in an FDA-QSR and ISO13485 compliant organization.

Requirements :

• Bachelor’s degree and 4+ years of experience in academic or industry setting. OR Master's degree or PhD with relevant work experience.
• Proficiency in molecular lab techniques, and ability to independently design and execute lab experiments with minimal guidance or direction.

Preferred Requirements:

• Execute statistically powered experiments with clinical specimens to verify assay performance.
• Demonstrate ability to drive to root cause of experimental problems as they arise, and trouble-shoot with stringent hypothesis testing methods any software, hardware, assay design, or consumables issues.
• Ability to prepare high quality technical documents on product design verification and validation for regulatory submissions.

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