Senior Software Business Analyst — Medical Device (Hybrid — Maple Grove, MN) - Contract
HybridMaple Grove, Minnesota, United States
Job Summary
Collaborate with cross-functional teams including product managers, engineers, QA, regulatory, and clinical experts to define software requirements for medical device products. Elicit, document, and manage business and functional requirements using industry-standard techniques, then translate complex clinical and business needs into detailed software requirements specifications. Act as the primary liaison between business stakeholders and development teams throughout the product lifecycle, ensuring solutions align with regulatory standards and risk management processes. Support software validation and verification efforts by reviewing test plans and ensuring requirements coverage, while participating in audits and regulatory submissions as needed. Facilitate requirement change management processes and impact analysis to contribute to continuous improvement initiatives within the software development and requirements management processes.
Required Qualifications
- 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
- Exceptional communication skills with the ability to convey technical concepts to non-technical stakeholders
- Strong analytical mindset and attention to detail
Desired Qualifications
- Experience with SaMD (Software as a Medical Device) or embedded systems
- Familiarity with HL7, FHIR, DICOM, or other healthcare interoperability standards
- Certification such as CBAP, PMI-PBA, or similar
- Proficiency with tools such as Jira, Confluence, Azure DevOps, and requirements management software such as Jama (highly preferred)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.