Medical Device Toxicologist II

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role: 

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.

 

Work Mode:

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

 

Relocation Assistance:

Relocation assistance is not available for this position at this time.

 

Visa Sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

Your responsibilities will include:

• 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. 

 

Required qualifications:

• A BS / MS degree in Toxicology is preferred, or closely related field (biology, chemistry, biochemistry, biomedical engineering).
• 2+ years’ experience supporting medical devices.
• 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. 

Preferred Qualifications:

• 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.

• A BS / M