Senior Validation Engineer

The Senior Verification Engineer will lead verification efforts for power contrast dye injection system disposables. This hands-on role involves developing and validating electro-mechanical test methods, fixtures, and equipment, as well as executing test cases, analyzing data, and reporting results. The ideal candidate has a strong mechanical engineering background, experience with disposable medical device testing, and a proven track record in design verification planning and execution.

• Develop and optimize test cases to support design verification strategies.
• Create and validate test methods for disposables testing, including:
• Test method instructions
• Validation protocols
• Validation execution and reporting
• Develop and qualify electro-mechanical test tools, fixtures, and equipment (IQ/OQ).
• Perform hands-on testing, analyze data using statistical techniques, and report defects.
• Support root cause investigations and recommend corrective actions.
• Develop and execute design verification protocols, and report results.
• Prepare and manage Test Readiness Reviews (TRR) ensuring documentation, materials, and tools are controlled and available.
• Estimate task effort and duration, track progress, and communicate status to stakeholders.
• Recommend improvements to test and verification SOPs and tools.
• Maintain compliance with Bracco Medical Technologies Quality Management System (QMS) and documentation requirements.

• Bachelor’s degree in Engineering (Mechanical or related field preferred).
• 5+ years of experience in the medical device industry
  .
• Strong knowledge of fluid and solid electro-mechanics and statistics.
• Experience testing disposable medical devices
  , including functional testing of components, assemblies, and systems.
• Proven experience designing and executing V&V test protocols and reports
  .
• Experience maintaining traceability between requirements, test cases, and test results.
• Detail-oriented with a rigorous mindset and ability to work independently.
• Proficient in Microsoft Office (Excel, Word, Outlook).
• Must be able to work on-site in Minneapolis, MN
  .

• Master’s degree in Mechanical, Electrical, or related engineering field.
• Knowledge of medical device regulations 21 CFR 820 and/or ISO 13485
  .
• Familiarity with ISO 14971 risk management.
• Experience with Jama or other requirements/test management tools, and Jira
  .
• Experience using Minitab for statistical analysis.
• Strong communication and interpersonal skills.
• Experience working in cross-functional and global teams.
• Experience with Scrum/Agile methodology
  .

• 60% – Develop and validate test methods; qualify tools/fixtures/equipment (IQ/OQ)
• 15% – Create and execute design verification protocols and reports
• 15% – Perform hands-on testing and data analysis
• 10% – Improve test methods and documentation