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, BiomeMinimum 1 year experience in a regulated industry, preferably in a medical manufacturing environment;
Minimum 1 year experience in a regulated industry, preferably in a medical manufacturing environment;
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;
Experience with vitro and in vivo (animal) test systems; and
Proficient in Microsoft Word/Excel/Power Point. Experience with reference data bases such as EndNote.
Works under general office environment conditions;
Utilizes close visual acuity for working with computers and equipment;
Frequently required to stand, walk, and hear;
Occasionally required to lift up to 20 pounds; and
Personal protective equipment including safety glasses, lab coat and gloves required in some areas associated with this position.