Principal Scientist Biocompatibility Toxicologist
4 weeks ago
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.
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