DDT Medical Device Investigation Analyst

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Job Description

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.

Responsibilities Include:

· 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.

Required Qualifications:

· 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.

Preferred Qualifications:

· 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).

Key Competencies:

· Investigation ownership and critical thinking

· Risk‑based decision making

· High‑quality technical documentation

· Cross‑functional collaboration in regulated environments

· Regulatory and compliance mindset.

Working Conditions:

· Hybrid office/remote environment

· May require flexibility to support investiga