Validation Engineer

About the Role

Test Engineer responsible for qualifying Automated Functional Testers within a medical device manufacturing environment. Will work closely with internal resources who write the tester code, completing all validation documentation and system qualifications. May also assist with assembling the hardware side of the testers.

Responsibilities

• Qualify automated functional test systems and support troubleshooting
• Write all validation documentation using healthcare templates, including requirements, trace matrices, protocols, and reports
• Execute verification and validation testing, document results, and manage deviations
• Collaborate with internal resources who write tester code to complete paperwork and qualify systems
• Assist with hardware assembly of the testers
• Ensure compliance with internal quality systems and regulatory standards
• Collaborate with cross-functional teams to support product testing and continuous improvement

Requirements

• Bachelor's degree in Engineering or related discipline
• 4-6 years of experience in verification and validation testing, preferably in medical devices or other regulated industries
• Experience with test system development for manufacturing
• Experience with manufacturing environment validations (IQ, OQ, PQ)
• Test Stand and LabView experience
• Manufacturing equipment validations (IQ/OQ/PQ) experience
• Familiarity with automated test systems and documentation best practices
• Strong analytical, documentation, and problem-solving skills

Preferred Skills

• Background in Test Stand and LabView to help debug and trace requirements
• MFG/PRO Domain (QAD) experience