Pharmavise Corporation

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

Pharmavise Corporation  •  Maple Grove, MN (Hybrid)  •  2 months ago
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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:
• Schedule: 08:00:AM - 04:30:PM CST
• Work Setup: Hybrid at Maple Grove, MN
• Contract Length: 6 Months
• Start Date:  9/2/2025
Pharmavise Corporation

About Pharmavise Corporation

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫.

𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻:

We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡.

𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬:

☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success.

☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.

☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.

𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆

Over 20 Technical Transfers and 30 product launches.

11 FDA remediations. Warning Letters and or Consent Decrees.

Cost savings and increased efficiency of over 10MM for clients

Industry
Consulting & Advisory
Company Size
11-50 employees
Headquarters
Fort Lauderdale, Florida
Year Founded
2013
Website
pharmavise.com
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