Biocompatibility Scientist 2

The Biocompatibility Scientist at Cook is responsible for assessing the safety of devices and related materials, assisting with writing risk assessments of medical devices, and ensuring the Cook device testing program is compliant to national and international regulatory guidelines.

Responsible for independently drafting biocompatibility assessments to comply with ISO 10993 standards and FDA guidance documents;

Carryout toxicological hazard assessment of raw materials and processing aids used in construction of medical devices;

Collaborate and clearly communicate with internal and external stakeholders to ensure appropriate planning, and execution of biocompatibility tests;

Analyze adequacy of biocompatibility test results utilizing analytical, problem-solving skills and technical knowledge to troubleshoot unexpected outcomes;

Work closely and assist Sr. Scientist - Toxicology & Biocompatibility in writing toxicological risk assessment reports on devices and materials; experience with chemistry of device materials and in silico test methods is a plus;

Utilize project management tools to help organize the various requests for biocompatibility evaluation and to ensure timely completion of testing;

Collaborate with Quality/Engineering/Supplier teams and with external vendors to procure material safety data sheets, certificate of analysis and purity of chemicals in order to assess safety of products;

Clearly disseminate information (verbal and/or written) to support regulatory submissions to global regulatory agencies; address requests from outside agencies on hazardous and regulated materials; and

Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Bachelor's degree in Toxicology, Biology, Biomedical Engineering, Material Science, or related field required, Masters preferred;

Experience with vitro and in vivo (animal) test systems;

Minimum of 1 year experience in a regulated industry, preferably in a medical manufacturing environment or scientific laboratory; Knowledge of GLP/GMP regulations, medical device materials; metals, plastics, resins and coatings; Experience in biocompatibility requirements of medical devices based on ISO 10993 and FDA guidance; Experience with Contract Testing Labs is preferred;

Proficient in Microsoft Word/Excel/Power Point;

Experience with reference data bases such as EndNote; and

Experience conducting literature reviews and reviewing scientific data.