Senior Medical Device Toxicologist

Geosyntec Consultants

United States, Massachusetts, Boston

Jan 24, 2025

Senior Medical Device Toxicologist

Primary Location

US-MA-Boston

ID

2025-3179

Category

Risk Assessment and Toxicology

Position Type

Regular Full-Time

Remote

Additional Location

US-VA-Charlottesville

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 join our growing practice in one of our office locations: downtown Boston, MA or Charlottesville, VA.

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

Willingness to learn 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 multi-team projects related to biomedical toxicological risk assessment and biocompatibility related projects.

Education and Licensure

Bachelor's degree in toxicology or related field. (required)
Advanced degree in toxicology or related field. (preferred)

Skills, Experience and Qualifications

At least 8 years (10+ years preferred) of environmental consulting experience; or equivalent combination of education and experience. (required)
Exceptional written and oral communication. (required)
Ability to work independently in a challenging and fast-paced work environment. (required)
Prior consulting or industry experience in medical device 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)

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