Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Location/Division Specific Information:
- South San Francisco, CA
- Genetic Sciences Division
How will you make an impact?
A pivotal member of the Genetic Testing Solutions Group who will work as part of a dynamic team of R&D professionals to execute on strategic IVD development projects. They will be responsible for defining, designing, and executing product development activities throughout all phases of the product development lifecycle process for clinical applications. They will work closely with core team leads to manage product development and execute on key objectives. This individual will be expected to exercise influence across functional teams and engage with internal and external stakeholders.
What will you do?
- Serve as R&D lead for large or multiple IVD product development projects from concept through development to market, aligning test strategies with regulatory strategy and meeting customer objectives.
- Own test method and strategy design; protocol execution; data analysis, and communication to project and business stakeholders.
- Collaborate and provide technical guidance to extended project teams to execute on project milestones.
- Work cross-functionally with R&D, Product Management, Quality, Regulatory, and Manufacturing to ensure that technical milestones, design transfer, customer satisfaction, and organizational goals are achieved.
- Influence the product design by contributing innovative ideas, assessing the suitability of product design and features to meet the needs of the customer, and ensuring the quality of the product through rigorous testing.
- Generate project documents including, test plans, protocols, and reports to meet regulatory and quality requirements per ISO13485 standards.