Senior Verification Engineer

Overview

The Senior Verification Engineer will be responsible for test and verification efforts related to power contrast dye injection system disposables. This hands-on role involves developing and validating electro-mechanical test methods, fixtures, and equipment. The engineer will lead test case development, execution, data analysis, and reporting.

The ideal candidate will have a mechanical engineering background, experience developing and validating tests for disposable medical devices, strong communication skills, and proven experience planning and executing medical device design verification.

• Develop and optimize test cases to implement planned design verification strategies defined by the Lead Verification Engineer.
• Develop and validate test methods to support disposables testing, including:
• Test method instructions
• Validation protocols
• Validation reports
• Develop and qualify electro-mechanical test tools, fixtures, software understanding, and equipment required to support defined test methods, including Installation Qualification (IQ) and Operational Qualification (OQ).
• Perform hands-on testing, analyze data using appropriate statistical techniques, and submit defects as observed. Participate in root cause investigations and recommend corrective actions.
• Develop design verification protocols, conduct or oversee 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 communicate status updates to stakeholders.
• Recommend improvements to 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 required documentation.

• Bachelor’s degree in Engineering (Mechanical or related scientific/technical field preferred).
• Familiarity with fluid and solid electro-mechanics and statistics.
• 5+ years of experience in the medical device industry.
• Experience testing disposable medical devices and performing functional testing of components, assemblies, finished goods, and systems following Good Laboratory Practice (GLP).
• Proven experience designing V&V test protocols and reports.
• Experience establishing and maintaining traceability between requirements, test cases, and test results.
• Strong attention to detail and rigorous mindset.
• Ability to work autonomously with minimal supervision.
• Proficiency with Microsoft Office (Outlook, Excel, Word, etc.).
• Ability to work onsite in Minneapolis, MN.

• Master’s degree in Engineering (Mechanical, Electrical, or related field preferred).
• Knowledge of medical device regulations including 21 CFR 820 and/or ISO 13485.
• 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 with excellent written and verbal communication.
• Ability to work effectively on cross-functional and international teams (systems, hardware, mechanical, quality, regulatory, etc.).
• Strong problem-solving and analytical skills.
• Experience with Scrum methodology.