Job Description

Are you an experienced Senior Software Business Analyst with a desire to excel? If so, then Talent Software Services may have a job for you! Our client is seeking an experienced Senior Software Business Analyst to work at their company in Maple Grove, MN.

Position Summary: We are seeking an experienced professional to join our dynamic team in the medical device industry. This role is critical to bridging the gap between clinical users, business stakeholders, and software development teams. 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 (e.g., FDA, ISO 13485, IEC 62304).

Primary Responsibilities/Accountabilities:

• 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 (e.g., user stories, use cases, process flows).
• Translate complex clinical and business needs into detailed software requirements specifications (SRS).
• Act as the primary liaison between business stakeholders and development teams throughout the product lifecycle.
• Ensure software solutions align with regulatory standards and risk management processes (e.g., design control, traceability, usability).
• Support software validation and verification efforts by reviewing test plans and ensuring coverage of requirements.
• Contribute to continuous improvement initiatives within the software development and requirements management processes.
• Facilitate requirement change management processes and impact analysis.
• Participate in audits and regulatory submissions as needed.

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 a 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.

Preferred:

• 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 is a plus.

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