Validation Engineer

Plan, execute, and document validation activities for non-product software systems in accordance with ISOxxxxxxxxxxxxxxxrequirements
Develop validation protocols including requirements specifications, risk assessments, test plans, and validation reports
Minimum 5 years of experience in software validation within a regulated medical device environment
Demonstrated knowledge of ISOxxxxxxxxxxxxxxxrequirements for non-product software validation
Proficiency in risk management techniques (FMEA, FTA) as applied to software systems
Strong understanding of 21 CFR Part 11 compliance for electronic records/signatures.