Validation Engineer

Overview

As a Systems Verification Engineer, you will be responsible for developing and optimizing test cases to implement planned design verification strategies. You will work closely with the Lead Verification Engineer to develop and validate test methods and support disposables testing, which includes test method instructions, validation protocols, and validation execution. Your role will involve qualifying electro-mechanical test tools, fixtures, and software necessary to support defined test methods.

This includes installation and operational qualifications (IQ/OQ).

• Develop and validate test methods to support disposables testing, including creating test method instructions, validation protocols, and executing validations.
• Qualify electro-mechanical test tools, fixtures, and software to support defined test methods, including installation and operational qualifications (IQ/OQ).
• Perform hands-on testing, analyze data using statistical techniques, and report defects if observed.
• Participate in root cause investigations and recommend corrective actions.
• Develop design verification protocols, conduct or oversee their execution, and report results.
• Organize protocol execution details, ensuring all documentation, materials, and tools are available and under control before execution as part of a Test Readiness Review (TRR).
• Estimate task effort and duration, monitor progress, and communicate status updates to stakeholders.
• Recommend improvements to organizational test and verification SOPs and tools.
• Adhere to the Quality Management System (QMS), including the development and maintenance of documentation.

• Bachelor's degree in engineering (Mechanical or a related scientific/technical field is preferred).
• Familiarity with fluid and solid electro-mechanics, and statistics.
• 5+ years of experience in the medical device industry.
• Experience in testing disposable medical devices and functional testing of components, assemblies, finished goods, and systems, following Good Laboratory Practice.
• Proven experience in designing V&V test protocols and reports.
• Experience establishing and maintaining traceability between requirements, test cases, and test results.
• Strong problem-solving and analytical skills.
• Proficiency in Microsoft Office (Outlook, Excel, Word, etc.).
• Ability to work on-site.
• Rigorous mindset and attention to detail.
• Autonomous and able to work with minimal supervision.

• Master's degree in engineering (Mechanical, Electrical, or a related scientific/technical field is preferred).
• Knowledge of medical device regulation 21 CFR 820 and/or ISO quality system.
• Knowledge of ISO risk management standard.
• Experience using requirements and test management tools and Jira for defect tracking.
• Experience using Minitab for statistical analysis.
• Strong interpersonal skills and excellent oral and written communication.
• Experience with Scrum methodology.
• Team player on internal/external and national/international teams across various disciplines (e.g., systems, hardware, mechanical, quality, regulatory).