Principal Scientist Biocompatibility Toxicologist

JobDescription

Gradient, an environmental consulting firm, isseeking a high energy individual to assist colleagues and clients by providingtechnical support for designing, conducting, and interpreting chemicalcharacterization studies for medical devices. Excellent benefits,friendly, hybrid work environment with a great location in downtown Boston, MA.

General Responsibilities:

• 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.

• Bachelors degree in Materials Science, Polymer Chemistry, Biomedical Engineering , Biochemistry, Chemistry, or other medical related discipline. (required)
• Masters 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. (required)
• Responsible for chemical qualifications on new and modified products as well as extractables and leachables testing. (preferred)
• Candidates must have excellent communication skills (verbal/written), as well as excellent quantitative and organizational skills.(required)
• 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 medical device material selection and manufacturing processes to evaluate patient/product safety. (preferred)
• Strong data management experience. (preferred)

Gradient provides employees with the right tools to meet challenges and to excel and grow both personally and professionally.