DDT Medical Device Investigation Analyst

Scorpion Therapeutics; Exton (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

Takeda is seeking a qualified candidate to lead investigations for medical device software and connected devices, ensuring compliance with FDA Quality System Regulations and MDR. The role involves managing complaint intake, conducting FDA-ready root cause analyses, and collaborating with Regulatory and Quality teams.

The position requires experience in regulated medical device investigations, SQL skills, and strong communication.

Qualifications

• Bachelor's degree in a related field (Computer Science, Life Sciences) and experience in regulated medical device investigations.
• Experience with root cause analysis and regulated investigations in a healthcare/medical device context.
• Knowledge of FDA QSR, ISO 13485 and regulatory reporting requirements.
• Proficiency in SQL, programming and maintaining technical documentation.
• Strong communication and risk decision-making skills.

Responsibilities

• Manage complaint intake.
• Conduct FDA-ready root cause investigations.
• Analyze system logs and code.
• Document findings and link issues to releases and change controls.
• Collaborate cross-functionally with Support, Product, Regulatory, and Quality teams.
• Support MDR reporting and audit responses.
• Identify trends and drive process improvements.
• Incorporate advanced reporting and AI tools.

Skills

Root cause analysis

Regulated investigations

SQL

Programming

Technical documentation

Communication skills

Risk decision-making

Education

Bachelor's in Computer Science

Bachelor's in Life Sciences

Tools

Power BI

Job description

Role

Lead investigations for medical device software and connected medical devices within Takeda's Plasma-Derived Therapies and BioLife operations, ensuring compliance with FDA Quality System Regulations and MDR.

Responsibilities

• manage complaint intake


• conduct FDA-ready root cause investigations


• analyze system logs and code


• document findings, and link issues to releases and change controls


• collaborate cross-functionally with Support, Product, Regulatory, and Quality teams


• support MDR reporting and audit responses


• identify trends and drive process improvements


• incorporate advanced reporting and AI tools

Requirements

• Bachelor's in Computer Science, Life Sciences, or related field


• 2-5 years in regulated medical device investigations, quality assurance, or healthcare IT


• knowledge of FDA QSR, ISO 13485


• experience with root cause analysis, regulated investigations, SQL, programming, and technical documentation


• strong communication and risk decision-making skills

Preferred

• experience with SaMD, digital health, plasma collection, biotech, FDA MDR, post-market surveillance, Power BI, and regulated environments


• prior FDA inspection support

High Value

medical device software/connected devices, regulated investigation, MDR compliance, FDA QSR, ISO 13485, Power BI, plasma/Biotech sectors.

Work Setup

• onsite in Bannockburn, IL, with other US locations


• full-time