Purpose and Passion - Comprehensive Benefits - Life:Work Integration - Community - Career Growth
At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we're solving some of the most important healthcare industry challenges. Together, we're one global team committed to making a difference in people's lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life's work.
About the Role:
The Biocompatibility Scientist II provides support for biocompatibility processes and related technical support to project teams in support of new product development, regulatory submissions, and manufacturing and engineering changes to meet business objectives. 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.
Your Responsibilities Include:
Working closely with internal R and D teams and external labs to design biocompatibility assessment strategies
Ensuring that adequate documentation exists for all the new and existing products to meet the existing and emerging regulatory requirements, particularly the EU Medical Device Regulations (EU MDR) and ISO 10993.
Coordinating recommended biocompatibility testing with external research labs, and assessing applicable test data Planning, leading or supporting protocol development, study management, data analysis and reporting of data
Writing Biocompatibility Assessment Reports
Other responsibilities include working closely with R and D, regulatory affairs, quality engineering, and manufacturing to support projects that need biocompatibility assessments.
What Were Looking For:
Academical Degree: BS, MS. or PhD in chemistry, biochemistry, biology, biomedical engineering, toxicology, or a related field
English Level required: B2+:(80:89)
Experienced professional with a complete understanding and wide application of principle, theories, and concepts in the Biocompatibility of medical devices, including demonstrated experience with ISO 10993
Excellent written and verbal communication skills
Results and detail:oriented, and able to multi:task while working against aggressive timelines
Comfortable in a dynamic environment and able to work independently as well as on teams
3+ years medical device biocompatibility experience
Experience working with regulated authorities
As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you're looking to truly make a difference to people both around the world and around the corner, there's no better place to make it happen.