Role: Business Analyst
Location: Santa Clara, CA
Rate Range : $40-$42/hr
Must Have Technical/Functional Skills
- 3-5 years of relevant Business Analyst experience, with a target of approximately 5 years.
- Minimum 2 years of experience in the medical device/MedTech sector, specifically supporting Regulatory Affairs and/or Clinical Affairs processes.
- Strong understanding of regulated medical device business processes, quality systems, documentation controls, and applicable regulatory expectations.
- Ability to Consultantly assess current-state workflows, identify pain points, control gaps, manual effort, and opportunities for AI-enabled automation.
- Experience translating business needs into clear problem statements, business requirements, functional requirements, user stories, acceptance criteria, and process maps.
- Working knowledge of AI, intelligent automation, workflow automation, analytics, and digital transformation concepts, including identification of appropriate use cases and business value.
- Ability to evaluate proposed solutions for regulatory, clinical, data privacy, quality, validation, traceability, and change-management considerations.
- Experience facilitating discovery workshops, stakeholder interviews, requirements reviews, and prioritization sessions.
- Strong analytical skills with proficiency in process mapping, gap analysis, root cause analysis, data analysis, and KPI definition.
- Proficiency with Microsoft Office tools, including Excel, PowerPoint, Word, Visio or equivalent process-mapping tools; experience with requirements or agile tools is preferred.
- Excellent written and verbal communication skills, with the ability to engage stakeholders from individual contributors through VP-level leadership.
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