Scientist

Senior Scientist

Santa Clara, CA

Pay rate: $40 an hour

Our clients long-term vision is to use digital technology as part of a holistic approach to surgery across the episode of care to enhance surgical efficiency, promote better clinical outcomes and increase patient satisfaction. This position will serve as a scientific contributor for the development and execution of preclinical evidence strategies necessary to competitively position a product for domestic and international regulatory and clinical acceptance.

Responsibilities Include

· Leads and supports product evaluations involving animate, inanimate, and cadaveric models

· Performs research supporting development of products or procedures in minimally invasive robotic surgery

· Assisting or conducting investigations for medical device development and preclinical evidence generation aligned to R&D, Regulatory, and Commercial needs

· Coordinate and ensure accurate documentation of laboratory activities

· Conduct lab activities in compliance with USDA, AAALAC, and Animal use policies

· Ensure compliance with 21 CFR Part 58 – Good Laboratory Practices

· Contribute and support the design of appropriate studies to meet premarket and post market needs

· Design, plan and execute preclinical animal studies for the assessment of safety, performance, and effectiveness

Act as study coordinator in support of the Study Director

Act as Study Director projects of varying levels of complexity

· Assess, communicate, and manage the risks associated to the preclinical evaluation of products.

· Assist in appropriate interpretation and dissemination of all evidence generated, based on evidence dissemination strategy, including study reports, abstracts, manuscripts, etc.

· Demonstrate the ability to work effectively in a team-oriented environment that embraces ownership and accountability for innovation, change, risk, and flexibility

· Build successful relationships internally and develop partnerships with key business partners

Qualifications

· A minimum of a bachelor’s degree in Biological Science or a related discipline is required.

Experience and Skills:

· A minimum of 5 years of related scientific / technical experience within preclinical research is required.

· Experience in preclinical science and processes along with an understanding of medical device development processes, related healthcare market environment, clinical trends, and preclinical regulations is required.

· Track record of contributing to preclinical programs on time, within budget and in compliance to SOPs and regulations is required.

· Experience working in a GLP environment and direct experience executing preclinical studies

· Understanding of good documentation practices

· Familiarity with animal welfare regulations and IACUC

Preferred:

· Experience working in Medical Devices or Robotics is preferred

· Experience working with large animal models is desired

· Experience in support of global regulatory submissions for medical devices, biologics, or drugs (including PMA/BLA/NDA and/or their global counterparts) is preferred.