Senior Software BA, Medical Device (Hybrid)

Pharmavise Corporation; Maple Grove (MN); Hybrid; USD 110,000 - 150,000; Part time

Job summary

Pharmavise Corporation in Maple Grove, MN is seeking a Senior Software Business Analyst to bridge clinical users, business stakeholders, and software teams in the medical device sector. This hybrid, contract role focuses on translating regulatory requirements into actionable software specifications.

The ideal candidate will have 5+ years as a BA, deep knowledge of FDA Design Controls, IEC 62304, ISO 13485, and experience with Jira, Confluence, Azure DevOps, and Jama, plus strong collaboration

Qualifications

• BA/BS or MS in Business, Engineering, CS, Biomedical Engineering, or related field.
• 5+ years as a Business Analyst, incl. 2+ years in senior/lead role.
• Experience in medical device or regulated healthcare software.
• Familiar with IEC 62304, ISO 13485, 21 CFR Part 11, FDA Design Controls.
• Knowledge of Agile, Scrum, and/or Waterfall methodologies.
• Proficiency with Jira, Confluence, Azure DevOps, Jama.

Responsibilities

• Collaborate with cross-functional teams to define software requirements for medical device products.
• Elicit, document, and manage business and functional requirements (user stories, use cases, process flows).
• Translate clinical and business needs into software requirements specifications (SRS).
• Act as liaison between stakeholders and development teams throughout the product lifecycle.
• Ensure solutions align with regulatory standards and risk management.
• Support software validation and verification by reviewing test plans and coverage.
• Contribute to continuous improvement of development and requirements processes.
• Facilitate requirement change management and impact analysis.
• Participate in audits and regulatory submissions as needed.

Skills

Communication

Analytical mindset

Regulatory knowledge

Agile/Scrum

Documentation

Education

Bachelor's or Master's in related field

Tools

Jira

Confluence

Azure DevOps

Jama

Job description

Pharmavise Corporation in Maple Grove, MN is seeking a Senior Software Business Analyst to bridge clinical users, business stakeholders, and software teams in the medical device sector. This hybrid, contract role focuses on translating regulatory requirements into actionable software specifications.

The ideal candidate will have 5+ years as a BA, deep knowledge of FDA Design Controls, IEC 62304, ISO 13485, and experience with Jira, Confluence, Azure DevOps, and Jama, plus strong collaboration