Boston Scientific Clinical Evaluation Scientist II 

United States, Massachusetts, Marlborough 

554714125

Costa Rica-Heredia; Costa Rica-Coyol; US-MN-Arden Hills

As a Clinical Evaluation Scientist II, you will analyze and communicate clinical product risk throughout the project and product lifecycle, providing guidance in safety signal detection and assessment to project teams and senior management. You will ensure compliance with regulatory standards, guidelines, and corporate procedures related to safety risk management. Working collaboratively in a team environment, you will systematically review and synthesize data from published medical literature to develop clinical documentation, including CERs, PMCF reports, and SSCPs, in alignment with clinical and regulatory standards. This role requires excellent writing skills, analytical thought processes, and a methodical clinical evaluation approach to develop benefit/risk profiles for Boston Scientific’s interventional cardiology devices. Your efforts will support product approval, indication expansion, claim support, and mandated post-market requirements.

Your responsibilities include:

• Identify scope and comparative information for CES/CRBA, collaborating with cross-functional partners for clinical risk analysis.
• Conduct literature searches to summarize harms, hazards, alternate therapies, and device-specific benefits; collect primary data from the Design History File.
• Generate risk management documents for BSC products to support internal and regulatory requirements.
• Serve as a liaison between Risk Management and project teams, communicating pertinent information.
• Collaborate with Clinical and R&D to develop clinical deliverable criteria and clinical trial rationalization plans; provide information for DFU, RAWB, and FMEA documents.
• Mentor and act as a subject matter expert in risk management activities, consulting on complex projects and product grouping.
• Serve as SME and Function representative in internal and external audits, preparing responses and supporting process improvements.
• Compile and evaluate data from clinical trials, medical literature, design verification/validation, and product complaints.
• Support the development of literature search strategies and methodical evaluation of medical literature.
• Create analyses to evaluate product benefit/risk profiles, safety, and performance objectives, and develop adverse event profiles.

Required qualifications:

• Minimum of a Bachelor of Science/engineering degree
• Minimum of 3 years of professional experience in clinical research
• Experience in clinical evaluation and EUMDR
• Strong analytical skills, including strong familiarity with scientific literature
• Strong medical/scientific writing skills

Preferred qualifications:

• Advanced degree (PhD, research-based MS)
• Knowledge of interventional cardiology/structural heart products and related disease states
• Medical device experience, including understanding of regulatory requirements
• Familiarity with citation management software

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.