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Boston Scientific Training Operations Specialist - Cardiology Structural Heart Valves 
United States, Minnesota, Maple Grove 
145306038

06.12.2024

About the Role

As the Training Operations Specialist, you will manage global training programs, quality assurance initiatives, and policies governing SHV Clinical Education. Partnering with Design Assurance, Medical Education, and Clinical Training teams, you will ensure effective execution and compliance with training processes, aligned with medical device regulations and Boston Scientific standards. Leveraging feedback and data insights, you’ll drive improvements in training processes while meeting HCP training needs throughout the product lifecycle—from early development to commercialization.

This hybrid role is based in Maple Grove, MN, requiring onsite presence three days per week.

Key Responsibilities:

  • Ensure compliance and oversight of SHV Healthcare Provider (HCP) and internal representative training programs, adhering to global regulatory requirements and internal policies.

  • Monitor the HCP training process for products by establishing compliance metrics and scorecards to measure implementation effectiveness.

  • Oversee monthly training records reconciliation and follow up on outstanding issues.

  • Use feedback and data analysis to drive training compliance and continuous improvement initiatives.

  • Lead corrective and preventive actions; proactively identify and implement preventive measures.

  • Collaborate cross-functionally to resolve technical and performance issues.

  • Act as a subject matter expert on training quality for internal and external stakeholders.

  • Develop and maintain comprehensive training programs aligned with the Global SHV Training strategy.

  • Create and execute innovative, engaging training solutions, resources, and tools that address curriculum needs.

  • Manage key projects supporting training and communication programs across regions, divisions, and functions.

  • Write and edit engaging, tailored content for Global Clinical aligned with the global clinical strategy.

  • Maintain tools and documentation reflecting operational processes related to training.

  • Cultivate internal relationships and a network of resources to ensure task completion.

  • Demonstrate commitment to patient safety and product quality, ensuring compliance with the Quality Policy and all documented quality processes and procedures.

Required Qualifications

  • Bachelor’s degree in a relevant field.

  • 5+ years of experience in a training operations role within a regulated environment (healthcare, pharma, or medical device preferred).

  • Experience documenting and tracking training compliance.

  • Strong communication and presentation skills.

  • Proven ability to collaborate effectively with cross-functional teams.

  • Proficiency in Microsoft Excel, Word, and PowerPoint.

  • Experience with data analysis for decision-making.

Preferred Qualifications

  • Knowledge of U.S. and international regulations and standards relevant to Boston Scientific, including:

    • 21 CFR 806 & 820

    • ISO 13485:2016

    • MDD, AIMD, MDR, CMDR, RDC, and JPAL

  • Familiarity with the medical device industry.

  • Experience with quality systems (e.g., eCAPA, Windchill, APPROVE).

  • Collaborative experience with Regulatory, R&D, Clinical, Medical, Sales Training, and Quality teams.

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.