JOB Location: Austin,TX
JOB Title: CSV Engineer
Experience 4-7 years
Medical device experience is a must
W2 & C2C

Key Words: Medical Software and Process Validation Eng, IQ,OQ,PQ, CFR21, ISO 14971, ISO 13485 Assembly, Electrical Engineer, Computer Science Test Scripts

Job Description

Software and Process Validation Engineer
•    Support the Validation team with all necessary quality and validation functions to assigned equipment
•    Interface with a variety of automated equipment and drive controls solutions to eliminate defects, improve cycle times, reduce machine downtime.
•    Develop equipment controls requirements and specifications.
•           Develop IQ/ OQ / PQ protocol's, approval follow up, execution, and monitoring performance
•    Prepare and maintain documentation related to the operation of the automation equipment.
•    Support within the IT team to assist in validation of IUD, MES & ERP systems.
•        Support the development and execution of master validation plans
•    Prepare validation plus acceptance criteria and evaluate test results to assure software attains requirements and parameters.
•    Help support SW validation engineering test plans, cases plus scripts.
•    Implement validation activities, system testing, acceptance testing.
•    Report software validation test results on structured way plus suggest
on deliverables quality.
•    Develop progress reports on activities assigned with an agreed upon frequency.

•    Bachelor’s in information technology, Computer Science, Life Sciences, or equivalent educational qualifications.

All your information will be kept confidential according to EEO guidelines.