Senior Medical Device Chemist

Gradient, a Geosyntec Company, is seeking a Senior Medical Device Chemist to design, conduct, and interpret chemical characterization studies for medical devices. You will have the opportunity to join our growing practice in our downtown Boston, MA office.

Gradient specializes 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/

The role involves making important contributions to patient safety by supporting medical device products through regulatory submission.
• Mastery 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 risks and compliance with current regulations.
• Ability to coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
• Design chemical characterization test plans in compliance with ISO 10993-18.

• Bachelor of Science/Engineering degree in Materials Science, Polymer Chemistry, Biomedical Engineering , Biochemistry, Chemistry, or other medical related discipline. (required)
• Master of Science/Engineering degree in Materials Science, Polymer Chemistry, Biomedical Engineering , Biochemistry, Chemistry, or other medical related discipline. (preferred)

• At least 10 years of experience at a medical device or consulting firm; or equivalent combination of education and experience. (required)
• Responsible for chemical qualifications on new and modified products as well as extractables and leachables testing.
• Candidates must have excellent communication skills (verbal/written), as well as excellent quantitative and organizational skills.
• Solid knowledge of polymer chemistry, and good understanding of the risk assessment process.
• The ability to learn quickly and work independently in a challenging and fast-paced work environment.
• Experience in managing multiple complex projects at once.
• Experience in medical device material selection and manufacturing processes to evaluate patient/product safety.
• Strong data management experience. (preferred)
• Candidates must currently hold and maintain valid U.S. work authorization. New H-1B visa lottery and employment based green card sponsorship are not available for this position.

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: $160,000/year / Maximum Salary: $185,000 /year (Boston, MA)

We offer a comprehensive benefits package including, paid holidays, vacation, sick, and personal paid time off, medical, dental, vision, life, and disability insurance, 401(k), and other benefits to eligible employees.