India-Maharashtra, Pune
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
A member of the Global Toxicology and Biocompatibility Department providing support for the Boston Scientific biocompatibility and toxicology processes; offering related technical support to assigned business divisions in support of new product development, regulatory submissions and design, manufacturing, process and vendor changes to current products to meet business objectives.
Your responsibilities include:
- Provides support for biocompatibility and toxicology 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.
- Demonstrates a primary commitment to patient safety and product quality.
- Under direction and mentorship of senior staff completes biological evaluations and toxicology risk assessments as necessary to support divisional 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
- Serves as a resource for biocompatibility and toxicology information for medical devices and pharmaceutical materials, which may include issues related to materials of animal origin, colorant additives, exposure assessments of chemicals, and other chemical toxicities as assigned.
- Communicates with internal customers on biocompatibility and toxicology issues and supports problem solving and resolution related to chemical risk assessments and biocompatibility assessments as assigned.
- Provides input on biocompatibility, chemistry and toxicology testing related to new investigational and strategic device development programs during Technology and Product development programs (TDP/PDP)
- Participates in a Biocompatibility Training Program for all functional groups of device development teams based on standards and regulatory requirements.
What We are Looking for
- Academical Degree: BS, or MS in Toxicology is preferred or an alternatively chemistry, biochemistry, biology, biomedical science or a related field degree qualification.
- English; excellent written and verbal communication skills.
- Professional with an understanding and application of principle, theories, and concepts in the biocompatibility of medical devices; experience with ISO 10993 preferred.
- Results and detail-oriented, and ability to multi-task while working against aggressive timelines.
- Comfortable in a dynamic environment and able to work independently as well as on teams.
- 1-3+ years medical device biocompatibility experience preferable or an equivalent combination of education and experience.
- Experience working with regulated authorities preferable.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!