Senior Verification Engineer - Medical Devices
Job Description
Job Title: Senior Verification Engineer - Medical Devices
Location: Minneapolis MN
Job Type: Full-Time
Position Summary
The Senior Verification Engineer is responsible for leading test and verification activities for power contrast dye injection system disposables. This is a hands-on role focused on developing, validating, and executing electro-mechanical test methods, fixtures, and equipment. The position involves test case development, execution, data analysis, defect investigation, and reporting in compliance with medical device quality and regulatory standards. The ideal candidate has a strong mechanical engineering background, experience with disposable medical device testing, and a proven track record in medical device design verification.
Primary Duties and Responsibilities
- Develop and optimize test cases aligned with design verification strategies defined by the Lead Verification Engineer.
- Develop, validate, and document test methods for disposables testing, including test instructions, validation protocols, execution, and validation reports.
- Design, develop, qualify, and maintain electro-mechanical test tools, fixtures, software interfaces, and equipment required to support defined test methods, including execution of Installation Qualification (IQ) and Operational Qualification (OQ).
- Perform hands-on testing, analyze test data using appropriate statistical techniques, and document results.
- Identify defects, submit defect reports, participate in root cause investigations, and recommend corrective and preventive actions.
- Develop design verification protocols, execute or oversee testing activities, and prepare comprehensive verification reports.
- Organize and manage protocol execution activities, ensuring readiness of documentation, materials, and tools through Test Readiness Reviews (TRRs).
- Estimate task effort and timelines, track progress, and provide regular status updates to stakeholders.
- Recommend and implement improvements to verification processes, SOPs, and testing tools to enhance efficiency and compliance.
- Perform all work in compliance with the Bracco Medical Technologies (BMT) Quality Management System (QMS), including creation, review, and maintenance of required documentation.
Qualifications
Minimum Qualifications
- Bachelor’s degree in Engineering (Mechanical or a related scientific/technical field preferred).
- Strong understanding of fluid mechanics, solid mechanics, electro-mechanical systems, and statistics.
- Minimum of 5 years of experience in the medical device industry.
- Hands-on experience testing disposable medical devices, including functional testing of components, assemblies, finished goods, and systems, in accordance with Good Laboratory Practice (GLP).
- Demonstrated experience designing and executing verification and validation (V&V) test protocols and reports.
- Experience establishing and maintaining traceability between requirements, test cases, and test results.
- Detail-oriented with a rigorous and quality-focused mindset.
- Ability to work independently with minimal supervision.
- Proficiency with Microsoft Office tools (Outlook, Excel, Word).
- Fluent in English (written and verbal).
- Ability to work on-site as required.
Preferred Qualifications
- Master’s degree in Engineering (Mechanical, Electrical, or related field).
- Knowledge of medical device regulations and standards, including 21 CFR 820 and/or ISO 13485.
- Familiarity with ISO 14971 risk management processes.
- Experience using Jama or similar requirements and test management tools, and Jira for defect tracking.
- Experience with statistical analysis tools such as Minitab.
- Strong interpersonal, written, and verbal communication skills.
- Proven ability to collaborate effectively with cross-functional teams, including systems, hardware, mechanical, quality, and regulatory teams across global locations.
- Strong analytical and problem-solving capabilities.
- Experience working within Agile or Scrum development environments.