Systems Verification Engineer

Overview

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, including 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, including installation and operational qualifications (IQ/OQ).

• 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.

• 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.

• 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).

The position involves working in an engineering lab, focusing on high-technology medical device testing. You will engage in hands-on testing and collaborate with various teams to achieve project goals.

This is a Contract position based out of Eden Prairie, MN.

The pay range for this position is $50.00 - $75.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:
This is an onsite position in Eden Prairie, MN.…