The role leads end-to-end investigations of Takeda developed software and connected medical devices to ensure FDA compliance
Job Summary
The role leads end-to-end investigations of Takeda developed software and connected medical devices to ensure FDA compliance.
Candidates must possess strong technical skills to reproduce defects and analyze code, logs, and database data to identify root causes.
The position offers a competitive base salary range of $89,900.00 to $141,240.00 along with comprehensive benefits including 401(k) matching and paid time off.
Matching Summary
The role leads end-to-end investigations of Takeda developed software and connected medical devices to ensure FDA compliance.
Salary
Base: $89,900.00 - $141,240.00; Bonus/Equity: Short-term and/or long-term incentives eligible; Benefits: Medical, dental, vision, 401(k), up to 120 hours vacation, 80 hours sick time
Skills & Requirements
Must-have
FDA QSR and ISO 13485 knowledge
Root cause analysis for medical devices
TrackWise documentation experience
SQL and programming language basics
ServiceNow IT ticket triage skills
Nice-to-have
Power BI dashboard creation
AI integration in compliance activities
Experience with plasma collection environments
Prior FDA inspection support
SaMD or digital health platform background
Key Requirements
Bachelor's degree in Computer Science, Life Sciences, or related field
2-5 years experience in medical device investigations or quality assurance