Clinical Risk Evaluation Intern

Additional Location(s):  N/A

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:

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three-four days per week.

 

We will consider qualified applicants of all ages who are starting (or restarting) their careers

 

Relocation and housing assistance may be available to those who meet the eligibility criteria.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time

 

As a Clinical Risk Evaluation Intern, you will work in a highly collaborative, team environment to develop global evidence-based clinical strategies for cardiology medical devices (Cardiac Rhythm Management) by creating clinical documentation that systematically synthesizes information from multiple data sources to support regulatory approval of medical devices globally. The ideal candidate will have a strong interest in engineering concepts, with an emphasis on how those concepts are applied within regulatory approval processes and curiosity about how engineering principles intersect with global regulatory requirements.

 

Your responsibilities will include:  

• Gain exposure to the manufacturing and development process for Class III medical devices in the cardiology space.
• Develop foundational knowledge of regulatory and Quality Management System (QMS) requirements for medical devices, including how manufacturers ensure safety, performance, and benefit.
• Collaborate with cross-functional teams, including Regulatory Affairs, Clinical Trials, Clinical Risk, Research and Development, and Design Assurance/Quality.
• Conduct state-of-the-art assessments for specific medical conditions treated or diagnosed by Cardiac Rhythm Management (CRM) devices, such as Cardiac Leads, Pacemakers, Subcutaneous Implantable Cardioverter-Defibrillators (S-ICDs), Transvenous Implantable Cardioverter-Defibrillators, and Cardiac Resynchronization Therapy – Defibrillators (CRT-D).
• Support experienced Clinical Risk specialists in achieving project milestones and deliverables.
• Contribute to ongoing monitoring and analysis of literature via screening published literature for relevant articles and extracting key safety, performance, and benefit data utilizing DistillerSR;
• Assist in the development and maintenance of key Clinical Risk documentation, including Clinical Evaluation Plans/Reports and Post-Market Clinical Follow-Up Plans/Reports.
• Review documents for accuracy and completeness prior to submission to regulatory bodies
• Participate in Clinical Risk and project team meetings, providing support for preparation, documentation, and follow-up activities.

 

Required Qualifications: 

• Must graduate between Fall 2026 – Spring 2027

• Currently pursuing a bachelor’s or graduate level degree majoring in Biomedical Engineering, Bioengineering, or Life Sciences

• Must be able to commit to one of the following full internship program periods: May 18th – August 7th OR May 26th – August 14th
• Must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization
• Must have reliable transportation to and from the Arden Hills, MN, Boston Scientific Corporate location
• Must have at least 3 months or more experience reviewing clinical data, evaluations, or trials
  
  

Preferred Qualifications:

• Strong analytical and quantitative skills;
• Excellent written and verbal communication skills;
• Stron