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Principal Development Validation Engineer- VALIDATION (BIOMEDICAL)
Lake Forest, IL (MUST BE ONSITE DAY ONE)
12+ month contracts
Interview Process
1st round TEAMS interview
Final round TEAMS panel interview
PRINCIPAL DEVELOPMENT ENGINEER
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 Design Verification Plans including test strategy
Utilize technical writing and statistical data analysis (Minitab) 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 discipline and 10 to 15 years related medical device experience, preferred in mechanical/chemical/biomedical engineering.
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.
Green Belt and/or Black Belt Certification a plus
Manufacturing operation experience a plus
Stellent IT LLC
