Clinical Evaluation Scientist II

Additional Location(s): US-MA-Marlborough; US-MN-Maple Grove

 

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:
This is a highly dynamic role in which you will work in a collaborative team-based environment to help develop global evidence-based clinical strategies for cardiology medical devices (i.e., Electrophysiology) by supporting the creation of clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist, you will support planning, development, and data analysis for clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio cardiology devices. A successful candidate has excellent writing skills, the ability to work collaboratively with cross-functional partners and manage simultaneous work on multiple different projects, and the ability to review and synthesize data from sources such as published articles. Your efforts will support product approval, indication expansion and claim support, and mandated post-market requirements.

 

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Arden Hills or Maple Grove, MN or Marlborough, MA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
 
Your responsibilities will include:

• Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes review of literature search strategies and methodical evaluation of medical literature
• Support document update activities including incorporating new data, analyzing impact of device design improvements, and other changes that impact existing clinical documentation
• Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps
• Collaborate with project leaders, leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification, ensure alignment of clinical data with risk documentation, and to contribute to product labeling
• Aid in the development and execution of strategies for regulatory responses for regulatory submissions

 
Required qualifications:

• Minimum of a bachelor’s degree in a science or engineering field
• Minimum of 3 years professional related experience

 
Preferred qualifications:

• Analytical skills, including familiarity with medical literature
• Medical/scientific writing skills 
• Knowledge of cardiac rhythm management and electrophysiology medical device products and related disease states/ medical terminology
• Medical device experience, including understanding of regulatory considerations
• Ability to understand engineering documentation, including risk documentation

 

#LI-hybrid

Requisition ID: 589613

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 meani