Systems Verifi cation Engineer

Systems Verifi cation Engineer

Location:

Eden Prairie, MN (Onsite) Duration: 9-month contract Experience

Required:

Minimum 5+ years

Position

Description:

As a Systems Verifi cation Engineer, you will be responsible for developing and optimizing test cases to implement planned design verifi cation strategies. You will work closely with the Lead Verifi cation Engineer to develop and validate test methods and support disposables testing, which includes test method instructions, validation protocols, and validation execution. Your role will involve qualifying electro-mechanical test tools, fi xtures, and software necessary to support defi ned test methods.

This includes installation and operational qualifi cations (IQ/OQ).

Responsibilities:

• Develop and validate test methods to support disposables testing, including creating test method instructions, validation protocols, and executing validations.
• Qualify electro-mechanical test tools, fi xtures, and software to support defi ned test methods, including installation and operational qualifi cations (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 verifi cation 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 eff ort and duration, monitor progress, and communicate status updates to stakeholders.
• Recommend improvements to organizational test and verifi cation SOPs and tools.
• Adhere to the Quality Management System (QMS), including the development and maintenance of documentation.

Essential

Skills:

• Bachelor's degree in engineering (Mechanical or a related scientifi c/technical fi eld is preferred).
• Familiarity with fl uid 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, fi nished 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.
• Profi ciency in Microsoft Offi ce (Outlook, Excel, Word, etc.).
• Ability to work on-site.
• Rigorous mindset and attention to detail.
• Autonomous and able to work with minimal supervision.