Senior Medical Device Toxicologist

Overview

Gradient, a Geosyntec Company, is seeking a Senior Medical Device Toxicologist to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. You will have the opportunity to work fully remote from your home-office in Tustin, California and join our growing practice supporting our Seattle, WA operations. Gradient is an environmental and health risk sciences consulting firm specializing in environmental sciences, human and ecological risk sciences, product stewardship, and life sciences. Gradient's scientists have a variety of backgrounds in chemistry, engineering, toxicology, epidemiology, ecotoxicology, medical device and pharmaceuticals, exposure sciences, industrial hygiene, GIS, product safety and liability, and sustainability. We invest in our people. Each employee is unique, and your career at Gradient will be too. We offer competitive pay and benefits, and well-being programs to support you and your family. To Learn More Visit:: http://www.geosyntec.com/careers/ Essential Duties and Responsibilities Possess in depth understanding of Biological Safety regulations (ISO 10993 and ISO 18562) and geography-specific requirements for both the USA and European Union to support regulatory submissions. Review and analyze technical data from multiple sources to assess potential toxicological risks and compliance to current regulations. Conduct strategic biological safety evaluation programs for medical devices that include: hazard identification, literature reviews, use of new and existing biological safety data, design of chemical characterization studies for extractables and leachables, and toxicological risk assessments. Coordinate with external labs to communicate test methods, sample submission, and review of test lab reports. Manage projects related to biomedical toxicological risk assessment and/or biocompatibility related projects. Education and Licensure Bachelor’s degree in toxicology or related field. (required) Advanced degree in toxicology or related field (strongly preferred) Skills, Experience and Qualifications At least 8 years (10+ preferred) in the field of medical device or pharmaceutical biocompatibility; or equivalent combination of education and experience (required) Exceptional written and oral communication (required) Excellent quantitative skills (required) The ability to work independently in a challenging and fast-paced work environment (required) Prior consulting or industry experience in medical device or pharmaceutical field, including managing projects with multiple staff (preferred) Strong data management experience (preferred) Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety (preferred) This opportunity will be posted for at least five days. Below are the potential compensation ranges that we in good faith believe are applicable for this role at the time of this posting and are only applicable for jobs to be performed in the specified location(s) below. The typical base salary range for this position is just one component of Geosyntec’s total compensation package for employees. Actual compensation will be determined based on education, experience, skill set and location. Minimum Salary: $129,105/year / Maximum Salary: $209,060/year (California, Washington) We offer a comprehensive benefits package to all eligible employees including, 9 paid holidays, 2 floating holidays, a minimum of 8 sick days, and a minimum of 11 vacation days per year, in line with state or federal requirements. Employees (and their families) are offered medical, dental, vision, life, and disability insurance, 401(k), a variety of leaves of absences and other benefits to eligible employees.