DDT Medical Device Investigation Analyst

Job Description
About the Role:

The DD&T US Medical Device Investigation Analyst, reporting to the Plasma-Derived Therapies (PDT) DD&T Operations Lead, is responsible for leading, coordinating, and documenting investigations related to Takeda-developed and owned software and connected medical devices used within U.S. PDT and Bio Life operations. This role ensures that device-related complaints, incidents, and quality events are investigated in a timely, compliant, and inspection-ready manner in accordance with FDA Quality System Regulations and Medical Device Reporting (MDR) requirements.

Working closely with DD&T, Quality, Medical Affairs, and Operations, the analyst identifies root causes, assesses potential patient and donor risk, and ensures appropriate linkage to MDRs, deviations, CAPAs, and continuous improvement initiatives. The role plays a critical part in maintaining product quality, regulatory compliance, and operational excellence across the PDT and Bio Life network.

• Manage end-to-end software medical device complaint intake, investigation, and closure, ensuring FDA/QMS compliance and on-time processing.
• Triage issues (including Service Now IT tickets) to determine complaint applicability, regulatory impact, and donor safety, eligibility, and data integrity risk.
• Execute FDA-ready investigations proportional to complaint significance, producing complete, defensible, inspection-ready records.
• Reproduce defects in qualified environments and analyzed application code, system logs, database data, and release artifacts to identify probable root cause.
• Document root cause or most probable cause with objective evidence and clear rationale when definitive conclusions were not possible.
• Link complaints to releases, builds, and change controls, ensuring full traceability across quality records.
• Author clear, concise complaint narratives in Track Wise, preserving reporter intent and supporting conclusions with complete evidence.
• Partner cross-functionally with Support, Product, and US based Regulatory and Quality teams to guide investigations and drive timely, compliant resolution.
• Create, review, and develop mitigation process and procedures for all identified complaints that have compliance risk without an immediate final resolution.
• Support MDR reportability assessments by providing investigation findings, timelines, and technical input in accordance with FDA 21 CFR Part 803 requirements for software devices.
• Participate in audit responses related to device investigations, complaints, and MDR activities. Participate in-person for all US based audits.
• Identify trends and contribute to continuous improvement of investigation processes and metrics.
• Provide required reporting on all DDT-related compliance activities including Complaint and quality record timeliness and department training.
• Work cross-functionally to incorporate AI and advanced reporting into all DDT compliance activities.
• Ensure all DDT teams are adequately training on quality related compliance activities.

• Bachelor’s degree in computer science, Life Sciences, Quality, or related technical discipline.
• 2-5 years of experience in medical device investigations, quality assurance, complaint handling, or regulated IT/healthcare environments.
• Working knowledge of medical device quality system requirements (FDA QSR, ISO 13485 concepts).
• Experience performing root cause analysis and documenting regulated investigations.
• Strong written documentation and cross-functional communication skills.
• Basic knowledge of SQL and at least one programming language.
• Investigation ownership and critical thinking
• Risk-based decision making
• High-quality technical documentation
• Cross-functional collaboration in regulated environments
• Regulatory and compliance mindset

• Experience with software as a medical device (SaMD) or digital health platforms.
• Familiarity with FDA MDR (21 CFR Part 803) and post-market surveillance support activities.
• Experience working in plasma collection, biotech, or highly regulated operational environments.
• Prior support of FDA inspections or quality audits.
• Experience with Power BI…