System Verification Engineer

Responsibilities

• Develop and optimize test cases to implement planned design verification strategies set by the Lead Verification Engineer.
• Develop and validate test methods to support disposables testing. This includes test method instructions, validation protocols, validation execution, and validation reports.
• Develop and qualify electro-mechanical test tools, fixtures, Software understanding and equipment necessary to support defined test methods. This includes installation and operational qualifications (IQ/OQ).
• Perform hands-on testing, analyze data using appropriate statistical techniques, and submit defects if observed. Participate in root cause investigation and recommend corrective actions.
• Develop design verification protocols, conduct or oversee their execution, and report results.
• Organize protocol execution details and ensure all documentation, materials, and tools are available and under control prior to execution as part of a Test Readiness Review (TRR).
• Estimate task effort and duration, monitor progress, and keep stakeholders up to date with status.
• Recommend improvements to the organizational test and verification SOPs and tools.
• Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation.

Qualifications (Knowledge, Skills & Abilities):

Minimum

• Bachelor's degree in engineering (Mechanical or a related scientific/technical field is preferred.
• Familiar with fluid and solid electro-mechanics, and statistics.
• 5+ years of experience in medical device industry.
• Experienced with 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.
• Autonomous, must be able to work with minimal supervision.
• Ability to work on site.

Preferred:

• 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 13485 quality system.
• Knowledge of ISO 14971 risk management standard.
• Experience using Jama or other requirements and test management tools and Jira for defect tracking.
• Experience using Minitab for statistical analysis.
• Strong interpersonal skills, excellent oral and written communication.
• Team player on internal/external and national/international teams across various disciplines (e.g., systems, hardware, mechanical, quality, regulatory).
• Strong problem solving and analytical skills.