Business Analyst Medical Devices

Dice is the leading career destination for tech experts at every stage of their careers. Our client, CS Solutions, Inc., is seeking the following. Apply via Dice today!Job Title: Business Analyst Medical DevicesLocation: Minneapolis, MN HybridDuration: 6+ MonthsJob DescriptionWe 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 ResponsibilitiesGather, analyze, and document business and functional requirements from stakeholdersWork closely with product owners, QA, and development teams to translate requirements into technical specificationsEnsure compliance with healthcare and regulatory standards such as FDA, ISO 13485, and HIPAAConduct gap analysis, impact analysis, and risk assessmentsSupport product lifecycle activities including design, development, validation, and post-market surveillanceCreate user stories, BRDs, FRDs, and use case documentationParticipate in UAT (User Acceptance Testing) and validation processesCollaborate with cross-functional teams including regulatory affairs, clinical, and quality teamsAssist in data analysis and reporting for product performance and improvementsRequired Skills & QualificationsBachelor s degree in Business, Life Sciences, Biomedical Engineering, or related field5+ years of experience as a Business Analyst, preferably in the medical devices or healthcare domainStrong knowledge of medical device regulations and standards (FDA, ISO 13485, IEC 62304)Experience with Agile/Scrum or Waterfall methodologiesProficiency in tools like JIRA, Confluence, MS Visio, ExcelStrong analytical, communication, and documentation skillsExperience in requirements traceability and validationWith Regards,Dinesh BCS Solutions, Inc7525 Mitchell Road, Suite 106, Eden Prairie, MN 55344Email ID -Direct Number