DDT Medical Device Investigation Analyst

Role: Lead investigations for medical device software and connected medical devices within Takeda's Plasma-Derived Therapies and BioLife operations, ensuring compliance with FDA Quality System Regulations and MDR. Responsibilities: manage complaint intake, conduct FDA-ready root cause investigations, analyze system logs and code, document findings, and link issues to releases and change controls; collaborate cross-functionally with Support, Product, Regulatory, and Quality teams; support MDR reporting and audit responses; identify trends and drive process improvements; incorporate advanced reporting and AI tools. Requirements: Bachelor’s in Computer Science, Life Sciences, or related field; 2–5 years in regulated medical device investigations, quality assurance, or healthcare IT; knowledge of FDA QSR, ISO 13485; experience with root cause analysis, regulated investigations, SQL, programming, and technical documentation; strong communication and risk decision-making skills. Preferred: experience with SaMD, digital health, plasma collection, biotech, FDA MDR, post-market surveillance, Power BI, and regulated environments; prior FDA inspection support. HighValue: medical device software/connected devices, regulated investigation, MDR compliance, FDA QSR, ISO 13485, Power BI, plasma/Biotech sectors. WorkSetup: onsite in Bannockburn, IL, with other US locations; full-time.