Validation Engineer

Company : Katalyst Healthcares & Life Sciences

Job Description:

• 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).

Responsibilities:

• 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.

Requirements:

• 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.

Additional Skills & Qualifications:

• 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).

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