Laboratory Project Specialist
Core
Lead planning, development, and execution of verification activities for medical device products, serving as a technical expert in device testing and design control.
Role type
Senior IC medical device verification engineer
Builds
Robust verification strategies and test methods for medical devices
Domain
Medical device engineering / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design verification strategy development, test method design and validation, statistical data analysis, technical reporting, risk analysis interpretation, design control compliance, cross-functional collaboration, mentorship
Preferred skills
Inhalation/drug delivery device experience, failure analysis methodologies, statistical software (Minitab/JMP), external lab management
Technologies
Minitab, JMP, ISO 13485, ISO 14971, IEC 60601, ISO 11608
Responsibilities
Develop and execute design verification strategies, create verification protocols and test plans, analyze test data and support root cause analysis, collaborate with R&D and Regulatory Affairs, mentor junior engineers, ensure compliance with design control requirements
Seniority
Senior, hands-on IC