Business Process Analyst I
About The Role
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.
Work Mode
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.
Your Responsibilities Include
Business Process Support
- 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.
Regulatory Compliance & Data Integrity
- 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.
Systems & Technology Support
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
Pay
Minimum Salary: $51000 Maximum Salary: $96900. The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).