The Research Fellow – Medical Device Toxicologist will provide cross‑functional preclinical medical‑device expertise supporting internal and external stakeholders on biocompatibility and related focus areas for medical device development, product expansion, and maintenance.
Responsibilities
- Manage a team responsible for medical device biocompatibility support
- Lead project strategies, risk assessments, biocompatibility evaluation plans, and reports for medical devices
- Ensure that development and execution of non‑clinical strategies align with product development, life‑cycle management activities, and regulatory expectations and milestones
- Ensure that essential non‑clinical data are obtained and effectively presented for successful clinical development, regulatory and quality compliance, market launch, and maintenance of business
- Coach and mentor junior staff
- Maintain deep understanding of medical‑device relevant standards and stay abreast of changes to applicable industry practice and guidance documents
- Implement new and revised standards into product development projects and assess impact on existing products as appropriate
- Author and review the department’s technical documents as needed
- Manage interactions with other functions (Product Development, Clinical Development, Analytical Chemistry, Regulatory, Quality, Compliance)
- Liaise with company international offices on non‑clinical safety matters for country‑specific submissions/registrations and maintenance of business activities
- Develop and maintain department best practices and processes
Requirements
- Ph.D. in Toxicology or related discipline
- 12+ years of relevant medical‑device industry experience
- Experience managing a team
- DABT preferred
- Ophthalmic medical‑device experience a plus
Benefits
- Medical, dental, eye‑health, disability and life insurance (beginning on your hire date)
- 401(k) plan with company match and ongoing contributions
- Paid time off – vacation (3 weeks prorated upon hire), floating holidays, and sick time
- Employee stock purchase plan with company match
- Employee incentive bonus
- Tuition reimbursement (select degrees)
- Ongoing performance feedback and annual compensation review
Location: US – Rochester, NY (GEHC)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Starting pay for this role is between $150,000.00 and $200,000.00. The actual base salary offered may depend on a variety of factors.
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