Business Analyst Medical Devices

Job Title: Business Analyst Medical Devices

Location: Minneapolis, MN Hybrid

Duration: 6+ Months

Job Description

We are seeking a detail-oriented Business Analyst with experience in the medical devices domain to bridge business needs and technical solutions. The ideal candidate will work closely with stakeholders, regulatory teams, and development teams to deliver compliant and high-quality solutions aligned with healthcare standards.

Key Responsibilities

• Gather, analyze, and document business and functional requirements from stakeholders
• Work closely with product owners, QA, and development teams to translate requirements into technical specifications
• Ensure compliance with healthcare and regulatory standards such as FDA , ISO 13485 , and HIPAA
• Conduct gap analysis, impact analysis, and risk assessments
• Support product lifecycle activities including design, development, validation, and post-market surveillance
• Create user stories, BRDs, FRDs, and use case documentation
• Participate in UAT (User Acceptance Testing) and validation processes
• Collaborate with cross-functional teams including regulatory affairs, clinical, and quality teams
• Assist in data analysis and reporting for product performance and improvements

Required Skills & Qualifications

• Bachelor s degree in Business, Life Sciences, Biomedical Engineering, or related field
• 5+ years of experience as a Business Analyst, preferably in the medical devices or healthcare domain
• Strong knowledge of medical device regulations and standards (FDA, ISO 13485, IEC 62304)
• Experience with Agile/Scrum or Waterfall methodologies
• Proficiency in tools like JIRA, Confluence, MS Visio, Excel
• Strong analytical, communication, and documentation skills
• Experience in requirements traceability and validation

With Regards,

Dinesh B

CS Solutions, Inc

7525 Mitchell Road, Suite 106, Eden Prairie, MN 55344

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