Senior Software Business Analyst — Medical Device (Hybrid — Maple Grove, MN) - Contract

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

Senior Software Business Analyst — Medical Device (Hybrid — Maple Grove, MN) - Contract

Maple Grove, United States

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Job Description

Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Software Business Analyst.

Job Summary

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).

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 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 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.

Other Details

• Work Setup: Hybrid at Maple Grove, MN

Pharmavise Corporation is an Equal Opportunity Employer and does not discriminate on the basis of race or ethnicity, religion, sex, national origin, age, veteran disability or genetic information or any other reason prohibited by law in employment.