Medical Device Toxicologist
Gradient, an environmental consulting firm is seeking a driven, high energy individual to assist colleagues and clients in toxicological risk assessments and biological safety evaluations for medical devices. Excellent benefits, friendly, hybrid work environment with a great location in downtown Boston.
Applicants should possess the following:
• 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.
• Ability to 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.
• Ability to coordinate with external labs to communicate test methods, sample submission, and review of test lab reports.
• Experienced in medical device material selection and manufacturing processes to evaluate patient/product safety is a plus.
Experience and Skills:
Position requires at least an M.S. in toxicology or related field. Candidates must have excellent writing and quantitative skills, and the ability to work independently in a challenging and fast-paced work environment. Prior consulting or industry experience in medical device field, including managing projects with multiple staff is a plus. Strong data management experience is a plus.
Gradient employees are recognized for their contributions and have the prospect to plan for future career development. We have an excellent track record growing leaders within our firm. Base salary is only part of your overall total compensation. The estimated annual base salary range for this position is $65k - $110k. Numerous factors are taken into consideration including education/training, experience, and geographical location, all of which are appraised during the interview process. Actual pay may be more or less than the posted range and does not include bonuses, overtime, or other forms of compensation or benefits.
Our benefits are comprehensive and include: medical and dental insurance, disability insurance (short- and long-term), life insurance; 401(k), Roth IRA, and a 3% company funded safe-harbor contribution retirement savings plan; a company-wide bonus program that incentivizes and rewards exceptional performance; a generous paid time off (PTO) benefit package, tuition reimbursement, professional development allowances, professional registration fee reimbursement, and company-paid public transportation options.
Gradient provides employees with the right tools to meet challenges and to excel and grow both personally and professionally.