Business System Analyst Job at JCW Group in Minneapolis

We’re supporting a medical device company seeking a Senior Software Business Analyst to join their software development team. This role will bridge clinical, business, and technical stakeholders to ensure software requirements meet both user needs and strict regulatory standards. This is a 6 month contract based positions with potential to extend.

What You’ll Do:

• Define, document, and manage software requirements (SRS, user stories, use cases)
• Act as liaison between business stakeholders and development teams
• Ensure alignment with FDA, ISO 13485, IEC 62304, and design controls
• Support verification, validation, and regulatory submissions

What We’re Looking For:

• 5+ years of experience as a Business Analyst, including senior/lead responsibilities
• Background in medical device or regulated healthcare software
• Strong knowledge of IEC 62304, ISO 13485, FDA Design Controls
• Proficiency with Jira, Confluence, Azure DevOps; Jama preferred
• Excellent communication and stakeholder management skills