Bus Proc Impvmt Analyst

Job Title:         Business Process Improvement Analyst

Client:              Medical Device Manufacturing Company
Duration:         12 Months | Possible Extension
Location:         Minneapolis, MN 55432
Shift:                1st Shift
Work Arrangement: Onsite

Description:

Job Summary

The Business Process Improvement Analyst will support process improvement, quality systems, configuration management, and product release activities within a regulated medical device environment.

The role will work with cross-functional teams to improve processes, analyze data, identify root causes, develop performance metrics, and support documentation and product release activities for Neuromodulation and Pelvic Health products, including labeling, packaging, manuals, and finished goods.

Key Responsibilities

Process Improvement

• Plan, perform, and implement process improvement initiatives, including Lean and Six Sigma activities.
• Diagram and evaluate existing processes to identify improvement opportunities.
• Organize, lead, and facilitate cross-functional project teams.
• Develop metrics to measure process performance and identify future improvement opportunities.
• Collect and analyze data to identify root causes of problems.
• Measure performance against established process requirements.
• Align improvement initiatives with identified performance gaps.
• Provide consultation on process re-engineering techniques to improve performance and product quality.
• Survey and analyze best practices for processes and improvement techniques.
• Perform cost-benefit analysis for improvement initiatives.
• Communicate project and team progress.
• Deliver presentations and training related to measurement, analysis, improvement, and control when required.

Configuration Management & Product Release

• Prepare and route Change Notifications (CNs) with Product Release and Configuration Assurance teams.
• Fulfill internal requests for electronic labeling documentation.
• Review components before CN release to ensure requirements and specifications are met.
• Create and maintain finished goods and models in a Product Lifecycle Management (PLM) system.
• Analyze and verify requirements for Unique Device Identification (UDI) registration.
• Support Device Master Record (DMR) indexing.
• Contribute to product release metrics and process measurements.

Quality Systems

• Coordinate product design documentation with Product Release and Quality Systems teams.
• Perform change-control audits of labeling and packaging components.
• Perform proofs of labeling components and print-vendor labeling.
• Follow applicable quality policies, procedures, and quality-system requirements.
• Ensure documentation and activities meet quality-system compliance requirements.

eManuals Release

• Perform the eManuals Release Administrator (ERA) role, including staging and releasing manuals to the eManuals website.
• Coordinate qualification and release activities for eManuals supporting product launches.
• Participate in user acceptance testing (UAT) as required.
• Follow established editorial guidelines for eManual records.
• Participate in requirements definition and testing for new eManual website features.
• Work with internal and external partners to troubleshoot content, quality, and schedule issues.
• Negotiate and coordinate resolution of release-related issues.

Required Qualifications

• Bachelor’s degree 2 years of job-related experience, OR
• Master’s degree 6 months of job-related experience.
• Strong process improvement and analytical skills.
• Strong attention to detail and accuracy.
• Ability to manage multiple priorities and adapt to changing requirements.
• Ability to work independently and as part of a cross-functional team.
• Proficiency with common software applications, including Microsoft Word, Excel, and Adobe Reader.
• Ability to learn and use proprietary software and systems.

Preferred / Nice-to-Have

• Experience working in a regulated environment.
• Experience in the medical device industry.
• Knowledge or experience with FDA, ISO, EN, and/or GMP standards.
• Experience with Lean or Six Sigma process improvement.
• Experience with quality systems, configuration management, or product release.
• Experience with process mapping, metrics, root-cause analysis, and performance measurement.
• Experience working with PLM, UDI, DMR, or electronic documentation systems.
• Strong cross-functional communication and project coordination skills.