Medical Device Toxicologist II

Boston Scientific • Marlborough, MA

238d • $72,800 - $138,300 • Hybrid

About The Position

The Medical Device Toxicologist II at Boston Scientific provides technical support for toxicology and biocompatibility processes to meet global business objectives. Additionally, this position is responsible for the biological evaluation of medical device products in accordance with ISO 10993, in support of new product development and sustaining activities (e.g. manufacturing and engineering changes), as well as in support of regulatory submissions. Global Toxicology and Biocompatibility plays a critical role in medical device development, ensuring patient safety while enabling early product development decisions, product design direction, product approvals, and market launch for product commercialization.

Requirements

• A BS / MS degree in Toxicology is preferred, or closely related field (biology, chemistry, biochemistry, biomedical engineering).
• Minimum of 2-3 years' experience supporting medical devices.
• Knowledge of the biological evaluation of medical devices (ISO 10993-1) preferred.
• Working knowledge of risk assessment methodologies, including the toxicological evaluation of medical device materials.
• Working knowledge of regulatory standards and global regulatory requirements with respect to medical device.
• Experience with running GLP and non-GLP studies.
• Excellent written and verbal communication skills.
• Results and detail-oriented.
• Able to multi-task while working against aggressive timelines.
• Comfortable in a dynamic environment and able to work independently as well as on teams.

Nice To Haves

• A BS / MS degree in Toxicology is preferred

Responsibilities

• Provide support for biocompatibility processes initiated by department management and ensure biocompatibility and toxicology related information and data are accurate, reliable, and support business objectives as consistent with Global Preclinical objectives and Quality Management System requirements.
• Demonstrate a primary commitment to patient safety and product quality.
• Under direction and mentorship of senior staff completes biocompatibility evaluations and safety assessments as necessary to support business objectives.
• Provides input on the regulatory requirements related to medical device submissions, on procedures, techniques, concepts and approaches used at divisional levels for biocompatibility and toxicology programs.
• May serve as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, color additives, exposure assessments of chemicals, and other chemical toxicities as assigned.
• Communicates with internal customers on biocompatibility and toxicology issues, supports problem solving and resolution related to related to biocompatibility assessments, chemical characterization, and toxicological risk assessments.
• Participates as assigned in training for functional groups of device development teams based on standards and regulatory requirements.
• Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs.

Benefits

• Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
• Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree