Previous Job
Previous
Validation Engineer II
Ref No.: 18-16420
Location: Lake Forest, Illinois
Development Engineer

Role Description
This role has primary responsibility for confirmation that medical devices and combination
products meet their intended function. This includes development of data through engineering
studies that informs new product development as well as test reports that support product
submissions. The candidate will work within a team environment to solve problems and utilize
best engineering practices and techniques for root cause and statistical analysis. This work entails
defining test methods, developing protocols, performing data analysis, and writing reports in
compliance with corporate procedures.

Responsibilities
• Partner with Systems engineers in defining product requirements such that they are verifiable
• Development of test fixtures, test methods, and performance of Test Method Validation activities
• Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
• Ensure integrity and compliance of data according to Standard Operating Procedures
• Develop Verification Plans including test strategy
• Utilize technical writing and statistical data analysis skills to write protocols and reports
• As necessary, conduct root cause analysis and derive recommendations based on analysis of data
• Translate inspections and tests methods into component and product specifications

Qualifications
B.S. in Engineering or science discipline and 2 to 5 years related experience. Familiarity with ISO standard test methods and related test instrumentation preferred. Excellent analytical and communication skills required. Ability to work and solve problems in team environment. Technical writing skills are required for protocol and report writing.