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Job Requirements of Senior Software Business Analyst:
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Employment Type:
Contractor
-
Location:
Maple Grove, MN (Onsite)
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Senior Software Business Analyst
Careers Integrated Resources Inc
Maple Grove, MN (Onsite)
Contractor
Job Title: Senior Software Business Analyst
Location: Hybrid Maple Grove, MN 55311
Department: R&D Software Development
Duration: 6-month W2 contract with strong possibility of extension based on performance and business needs
Pay Range: $40 to $49.63 per hour
Shift Timing: 08:00:AM - 04:30 PM CST
About the Role
We are seeking an experienced Senior Software Business Analyst to join our team in the medical device industry. This role is vital in bridging clinical users, business stakeholders, and software development teams. The ideal candidate will have strong analytical skills, deep knowledge of software development practices, and a solid understanding of regulatory and compliance requirements specific to healthcare and medical device software (e.g., FDA, ISO 13485, IEC 62304).
Key Responsibilities
Qualifications
Preferred Qualifications
Why Join Us?
Work with cutting-edge medical technologies that improve patient outcomes. Collaborate with world-class professionals in a mission-driven organization committed to innovation, compliance, and quality.
Location: Hybrid Maple Grove, MN 55311
Department: R&D Software Development
Duration: 6-month W2 contract with strong possibility of extension based on performance and business needs
Pay Range: $40 to $49.63 per hour
Shift Timing: 08:00:AM - 04:30 PM CST
About the Role
We are seeking an experienced Senior Software Business Analyst to join our team in the medical device industry. This role is vital in bridging clinical users, business stakeholders, and software development teams. The ideal candidate will have strong analytical skills, deep knowledge of software development practices, and a solid understanding of regulatory and compliance requirements specific to healthcare and medical device software (e.g., FDA, ISO 13485, IEC 62304).
Key Responsibilities
- Collaborate with 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 such as user stories, use cases, and process flows.
- Translate complex clinical and business needs into detailed Software Requirements Specifications (SRS).
- Serve as the primary liaison between business stakeholders and development teams throughout the product lifecycle.
- Ensure software solutions comply with regulatory standards and risk management processes (e.g., design control, traceability, usability).
- Support software validation and verification by reviewing test plans and ensuring full requirements coverage.
- Contribute to continuous improvement of software development and requirements management processes.
- Facilitate requirement change management 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 a 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 Jira, Confluence, Azure DevOps, and requirements management tools such as Jama (highly preferred).
- Exceptional communication skills, able to convey technical concepts to non-technical stakeholders.
- Strong analytical mindset and attention to detail.
Preferred Qualifications
- Experience with SaMD (Software as a Medical Device) or embedded systems.
- Familiarity with healthcare interoperability standards such as HL7, FHIR, DICOM.
- Relevant certifications like CBAP, PMI-PBA, or similar are a plus.
Why Join Us?
Work with cutting-edge medical technologies that improve patient outcomes. Collaborate with world-class professionals in a mission-driven organization committed to innovation, compliance, and quality.
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