DDT Medical Device Investigation Analyst

Role: Investigations Analyst for medical devices within Takeda's Plasma-Derived Therapies (PDT) and BioLife operations, focusing on software and connected medical devices. Responsibilities: manage end-to-end complaint investigations, ensure FDA/QMS compliance, assess patient and donor risk, link complaints to change controls, author investigation reports, support MDR reporting, and participate in audits. Collaborate cross-functionally with Quality, Medical Affairs, Regulatory, and Support teams to resolve device issues and implement continuous improvement. Requirements: Bachelor’s in computer science, Life Sciences, or related; 2–5 years in medical device investigations, quality assurance, or regulated IT healthcare environments; knowledge of FDA QSR, ISO 13485; basic SQL and programming skills; strong documentation and communication skills; investigation ownership and risk decision-making. Preferred: experience with software as a medical device (SaMD), digital health platforms, FDA MDR, plasma/biotech environments; familiarity with Power BI and post-market surveillance. High-Value: focus on FDA-regulated software medical devices, complaint handling, MDR compliance, audit participation, and cross-functional collaboration in highly regulated biotech settings. Work Setup: based in Bannockburn, IL, with full-time, exempt employment.