Boston Scientific Clinical Evaluation Scientist II 

United States, Minnesota, Arden Hills 

520095271

US-MA-Marlborough; US-MN-Maple Grove

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

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.