JCW Group
Business System Analyst Job at JCW Group in Minneapolis
JCW Group, Minneapolis, MN, United States, 55400
Overview
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 user needs and regulatory standards. This is a 6-month contract-based position 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
Seniority level
- Mid-Senior level
Employment type
- Contract
Job function
- Analyst and Consulting
Industries
- Medical Equipment Manufacturing