Senior Business​/Systems Analyst – AI Solutions

I am seeking an experienced Business/Systems Analyst with expertise in Artificial Intelligence to support Quality, Post-Market Surveillance, and Product Investigation functions within a regulated medical device environment.

This role will evaluate departmental processes, systems, and data flows to design and implement compliant AI-driven solutions that enhance trend detection, complaint analysis, and product investigation workflows.

The ideal candidate understands both AI technologies and the regulatory requirements governing medical device quality systems.

The position is full-time on-site in Minnesota.

• Assess current-state workflows related to complaints, product investigations, CAPA, and post‑market surveillance.
• Map data flows across QMS, ERP, complaint handling systems, and laboratory analysis systems.
• Identify opportunities for AI‑enabled automation and develop user requirements to ensure maximum usability.

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Data Science, or related field.
• 5+ years of experience in Business or Systems Analysis within a regulated medical device or life sciences environment.
• Experience working within Quality Systems (complaints, investigations, CAPA, PMS).
• 2+ years of hands‑on AI/ML solution development experience.
• Experience with NLP and structured/unstructured data processing.
• Proficiency in Python, SQL, and common ML frameworks.
• Demonstrated ability to document technical systems for regulatory environments.