DDT Medical Device Investigation Analyst

Takeda•Bannockburn, IL

6d•$89,900 - $141,240•Hybrid

About The Position

The DD&T US Medical Device Investigation Analyst is responsible for leading and documenting investigations related to Takeda developed & owned software and connected medical devices used in US PDT and BioLife operations. This role ensures that device related complaints, incidents, and quality events are investigated in a timely, compliant, and inspection ready manner, supporting FDA Quality System and Medical Device Reporting (MDR) requirements. The specialist works closely with DD&T, Quality, Medical Affairs, and Operations to identify root cause, assess patient and donor risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities.

Requirements

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.

Nice To Haves

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 (including building reports and dashboards).

Responsibilities

Manage end-to-end software medical device complaint intake, investigation, and closure, ensuring FDA/QMS compliance and on-time processing.
Triage issues (including ServiceNow 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 TrackWise, 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.