Business Process Analyst

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.

The Business Process Analyst I supports Device Tracking Operations by analyzing, documenting, and improving business processes that ensure compliance with applicable regulatory requirements and Boston Scientific quality standards. This role works closely with Device Tracking Operations, IT, Regulatory Affairs, Quality, and business stakeholders to identify process improvement opportunities, support system enhancements, investigate operational issues, and ensure the accuracy and integrity of device tracking data.

The analyst assists in maintaining and optimizing end-to-end device tracking processes, including device registration, data management, reporting, system integrations, and process compliance activities.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least three (3) days per week.

Relocation assistance is not available for this position at this time.

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

• Analyze and document current and future-state device tracking processes.
• Assist in identifying process inefficiencies and opportunities for operational improvement.
• Participate in cross-functional projects supporting device tracking systems and processes.
• Support implementation of process changes, system enhancements, and corrective actions.
• Develop and maintain process maps, work instructions, business requirements, and supporting documentation.

• Support activities required to maintain compliance with applicable device tracking regulations and internal quality requirements.
• Perform investigations related to device data discrepancies and tracking issues.
• Assist with data quality monitoring, trending, and remediation activities.
• Evaluate business processes for compliance risks and recommend corrective actions.
• Support audit preparation and responses by gathering documentation and process evidence
• Collaborate with IT and system owners to gather business requirements for system enhancements.
• Participate in User Acceptance Testing (UAT), validation activities, and defect resolution.
• Investigate device tracking system issues and support resolution efforts.
• Assist with implementation and sustainment of Global Medical Device Tracking (GMDT) and other supporting systems.
• Support user inquiries and troubleshooting activities.

• Bachelor's degree in Business, Engineering, Life Sciences, Information Systems, Healthcare Administration, or related field.
• 0-3 years of experience in business analysis, quality systems, operations, regulatory compliance, healthcare, or medical device environments.
• Analytical and problem-solving skills.
• Experience working with Microsoft Office applications, including Excel.
• Ability to analyze data and translate business needs into process improvements.
• Strong written and verbal communication skills.
• Ability to work effectively on multiple priorities in a cross-functional environment.

• Experience in medical device, healthcare, quality, or regulated industry.
• Knowledge of FDA regulations, quality systems, or post-market surveillance processes.
• Experience with SAP, Salesforce, Appian, or device tracking systems.
• Experience with process mapping, requirements gathering, root cause analysis, and continuous improvement methodologies.
• Familiarity with validation, CAPA, audit support, or regulatory reporting activities.

Minimum Salary: $51000

Maximum Salary: $96900

The…