Business Process Analyst I

Boston Scientific•Arden Hills, MN

2d•$51,000 - $96,900•Hybrid

About The Position

The Business Process Analyst I supports business process and system improvements that enhance operational efficiency, data integrity and regulatory compliance. This role partners with cross-functional stakeholders to analyze current processes, document business requirements, support testing activities, maintain process documentation and contribute to continuous improvement initiatives. The analyst serves as a key resource in ensuring business processes and systems effectively meet organizational needs while supporting Device Tracking and Medical Records operations. At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our Arden Hills, Minnesota, office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Requirements

Bachelor's degree in business administration, information systems or a related field.
Familiarity with enterprise systems such as GMDT, SAP, Salesforce, Jira or Windchill.
Knowledge of data cleansing and data analysis techniques.
Demonstrated analytical and problem-solving skills with the ability to assess the impact and risk of changes to business processes and systems.
Demonstrated written and verbal communication skills with the ability to collaborate effectively with cross-functional stakeholders.
Ability to create, edit and maintain standard operating procedures (SOPs), work instructions and training documentation.
Understanding of FDA regulations, including 21 CFR Part 821, governing medical device tracking.

Nice To Haves

Experience in business process analysis within the medical device or another regulated industry is preferred but not required.
Experience working within a quality system or another regulated environment.
Experience supporting business process improvement or continuous improvement initiatives.
Exposure to requirements gathering, user acceptance testing (UAT) or system implementation activities.
Knowledge of Lean, Six Sigma or other process improvement methodologies.

Responsibilities

Assess device configurations and statuses, ensuring timely follow-up with internal and external stakeholders.
Apply appropriate medical procedure information to support downstream complaint handling activities.
Investigate, process and maintain patient medical records with a high level of accuracy and confidentiality.
Ensure the completeness, accuracy and quality of incoming documentation.
Collaborate with internal teams to gather, validate and maintain accurate patient and device data.
Handle incoming and outgoing customer communications by phone and in writing in a professional and responsive manner.
Process routine, critical and expedited requests related to medical record operations.
Prepare clear, professional written communications to support investigations and respond to customer inquiries.
Maintain documentation in accordance with quality system requirements and controlled procedures.
Participate in regulatory and FDA-mandated activities supporting medical device tracking compliance.
Ensure adherence to data accuracy, traceability and confidentiality requirements.
Support assessments of the impact and risk of changes to existing and new systems and business processes affecting Device Tracking and related systems.
Identify opportunities to improve process efficiency, effectiveness and data quality.
Contribute to process improvement initiatives and workflow optimization efforts.
Represent Device Tracking on cross-functional discussions and projects, as needed.
Support the gathering of business requirements and execution of test scenarios for system enhancements.
Create, update and maintain standard operating procedures (SOPs), work instructions and training materials.
Support implementation of process improvements in collaboration with cross-functional partners.
Identify and escalate process gaps, risks and data quality issues.