Business Process Analyst III

Department: R&D Software Development
Location: Maple Grove
Job Type: Full-Time/ Hybrid
Industry: Medical Device
About the Role
We are seeking an experienced Senior Software Business Analyst 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).
Key Responsibilities
• 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 requirements coverage.
• 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 Masters 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.
Preferred 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 is 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 focused on innovation, compliance, and quality.
If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands - Manpower, Experis, Talent Solutions, and Jefferson Wells - creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.