Clinical Research Engineer - Future Forward
Sunnyvale, CA, United States On-site
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About the role
The Clinical Research Engineer uses their in-depth clinical, scientific, and technical knowledge to collaborate with engineers, physicians, user experience researchers, and other internal and external stakeholders to develop new product concepts being incubated in early exploration. The individual brings their clinical device development expertise to new platform and technology development, and is responsible for identifying, documenting, and understanding user needs and subsequently communicating these needs to inform concept design and development. The Clinical Research Engineer is responsible for developing and executing an experimental strategy to assess performance and safety of prototype designs and is a key contributor in the design and development iteration process. The individual will take an active role in the concept design team by assessing and communicating clinical risks, providing design guidance, inventing new concepts, and executing the overall clinical strategy. The Clinical Research Engineer also partners closely with team members such regulatory, clinical affairs, finance, and more to develop the clinical indication and commercialization strategy.
What you'll bring
- Minimum of a B.S. in Biomedical Engineering, Mechanical Engineering, or similar
- 5+ years of related experience in clinical engineering and/or product development within the medical device industry
- Fluent in medical procedure terminology and sound knowledge of anatomy
- Ability to understand complex robotic systems and software algorithms.
- Experience working in an operating room or interventional suite environment.
- Experience collaborating with physicians and collecting feedback on clinical use of the product.
- Excellent mechanical and technical aptitude, and intuition for spatial relations, including the ability to understand complex mechanical products.
- Excellent analytical capability and practical skills to develop and test a clinical hypothesis and draw succinct conclusions.
- Excellent teamwork skills with proven ability to cultivate collaboration across multiple disciplines to ensure timely project success.
- Proven success recognizing critical issues and driving them to closure by taking coordinated action.
- Product development and Design Controls experience required.
- Familiar with intellectual property development and patent assessment