DDT Medical Device Investigation Analyst

Role: Investigations Analyst in US Medical Devices within Takeda's Plasma-Derived Therapies (PDT). Responsible for leading, coordinating, and documenting investigations of software and connected medical devices used in PDT and BioLife operations, ensuring compliance with FDA QSR, MDR, and quality standards. Responsibilities include managing complaint intake, conducting thorough investigations, reproducing defects, identifying root causes, linking issues to change controls, authoring investigation records, and supporting MDR reporting. The role involves cross-functional collaboration with Quality, Medical Affairs, Support, and Regulatory teams, and participating in audits. Qualifications: Bachelor's in computer science, life sciences, or related field; 2-5 years in medical device investigations, quality assurance, or regulated IT environments; knowledge of FDA QSR, ISO 13485; experience with root cause analysis, regulated investigations, and basic SQL/ programming skills. Preferred skills include experience with software as a medical device (SaMD), digital health platforms, FDA MDR, and Power BI. High-value specifics: focus on software medical devices, post-market surveillance, and FDA compliance; based in Bannockburn, IL, with a salary range of $89,900–$141,240; full-time, exempt role.