Analyst - Business Process Analyst III

• Job Title: Business Analyst

• Location: Maple Grove, MN – Hybrid

• Duration: 6 Months

• Shift: Monday to Friday – Day Shift

• Schedule: Full-Time
• Pay Rate: $51.28/hr.
   

The Senior Software Business Analyst bridges clinical, regulatory, and software development teams to define and manage requirements for medical device software. This role supports design control, regulatory compliance (FDA, ISO 13485, IEC 62304), and software verification/validation while driving continuous process improvements.

• Education:

  • Bachelor’s or Master’s in Business, Engineering, Computer Science, Biomedical Engineering, or related field

• Licensure & Certifications:

  • CBAP, PMI-PBA (Preferred)

• Required Skills & Experience:

  • 5+ years as a Business Analyst (2+ years in a senior role)

  • Experience in medical device or regulated healthcare software

  • Knowledge of IEC 62304, ISO 13485, FDA Design Controls, 21 CFR Part 11

  • Agile/Scrum or Waterfall methodology experience

  • Skilled in Jira, Confluence, Azure DevOps; Jama (highly preferred)

  • Strong communication, stakeholder management, and analytical skills

• Preferred Skills & Experience:

  • Experience with SaMD or embedded systems

  • Familiarity with HL7, FHIR, DICOM or interoperability standards