Role OverviewOur Fortune 500 Medical Device client has an exciting opportunity for a Senior Software Business Analyst. This role is critical to bridging the gap between clinical users, business stakeholders, and software development teams.
What You Will Do
Collaborate with cross-functional teams to define software requirements, elicit and document business and functional requirements, and translate complex clinical and business needs into detailed software requirements specifications.
Why It Might Be a Fit
The ideal candidate will possess strong analytical skills, in-depth knowledge of software development practices, and a deep understanding of regulatory and compliance requirements specific to healthcare and medical device software.
Requirements
- Bachelor's or Master’s degree in Business, Engineering, Computer Science, Biomedical Engineering, or related field
- 5+ years of experience as a Business Analyst, including at least 2 years in a senior or lead role
- Proven experience in the medical device industry or regulated healthcare software environment
- Strong knowledge of IEC 62304, ISO 13485, 21 CFR Part 11, and FDA Design Controls
- Solid understanding of Agile, Scrum, and/or Waterfall methodologies
- Proficiency with tools such as Jira, Confluence, Azure DevOps, and requirements management software such as Jama (highly preferred)
- Exceptional communication skills with the ability to convey technical concepts to non-technical stakeholders
- Strong analytical mindset and attention to detail
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