Boston Scientific Training Operations Specialist Clinical Education Structural Heart 

United States, Minnesota, Maple Grove 

237449090

About the role:

The Training Operations Specialist is responsible for maintaining global training programs, quality assurance initiatives, and policies governing the training processes for SHV Clinical Education. In this role, you will collaborate with the Design Assurance, Medical Education, and Clinical Training teams to ensure the effective execution and compliant implementation of physician training, aligned with medical device standards, regulations, and Boston Scientific requirements. Leveraging feedback and data-driven insights, you will drive continuous improvement in training processes. You will also work closely with Marketing, Sales, Clinical, R&D, and Design Assurance teams to assess and meet HCP training needs throughout the product development cycle, from early stages to commercialization.

Your responsibilities will include:

• Support compliance oversight of the SHV HCP and internal training programs to meet internal and external regulatory requirements across all applicable geographies
• Monitor the HCP training process for products by establishing compliance metrics and scorecards to ensure effective implementation of the training process and associated records
• Oversee the monthly training records reconciliation process and ensure follow-up on outstanding issues
• Drive training compliance and use feedback to enable data-driven decisions for continuous improvement
• Lead corrective and preventive actions as needed; proactively identify and execute opportunities for preventive measures
• Collaborate cross-functionally to identify and resolve technical and performance issues
• Serve as a subject matter expert on the quality aspects of training for internal and external customers
• Implement and maintain components of a comprehensive training program for Global SHV Training
• Create, support, and execute innovative and engaging training and educational solutions, resources, and tools to align with the Global SHV training strategy and respond to curriculum needs
• Execute projects that support the development and enhancement of training and communication programs spanning multiple regions, divisions, and functions
• Support the training strategy by writing and editing engaging and tailored content for Global Clinical, aligned with the global clinical strategy
• Manage key training projects, including Educare and digital initiatives
• Maintain tools and documentation that reflect operational processes related to training
• Cultivate internal relationships and develop a network of resources to facilitate task completion
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Required Qualifications:

• Bachelor’s degree in science, healthcare, engineering, or a related field.
• 5+ years of experience in the medical device, pharmaceutical, or other regulated industry.
• Experience working with quality systems and controlled processes.
• Demonstrated ability to present information clearly and communicate effectively.
• Proven ability to work collaboratively with cross-functional teams.
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Experience using data analysis to support decision-making.

Preferred Qualifications:

• Working knowledge of U.S. and international regulations and standards relevant to BSC, including 21 CFR 806 & 820, ISO 13485:2016, MDD, AIMD, MDR, CMDR, RDC, and JPAL.
• Experience in medical education.
• Familiarity with BSC IS systems (e.g., eCAPA, Windchill, APPROVE) preferred.
• Experience collaborating with cross-functional teams such as Regulatory, R&D, Clinical, Medical, Sales Training, and Quality.

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.