Systems Verification Engineer

Pentangle Tech Services | P5 Group; Eden Prairie (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Pentangle Tech Services | P5 Group in Eden Prairie, MN, seeks a Systems Verification Engineer to develop and validate test methods, including IQ/OQ, and to support disposables testing across the product portfolio.

Requires a 5+ year track record in medical devices, strong data analysis, and the ability to work on-site with cross-functional teams to ensure robust verification and documentation.

Qualifications

• Bachelor's degree in engineering (Mechanical preferred).
• 5+ years in the medical device industry.
• Experience testing disposable medical devices and components.
• Proven ability to design V&V protocols and reports.
• Maintain traceability between requirements, test cases, and results.
• Strong problem-solving and analytical skills.

Responsibilities

• Develop and validate test methods and validations.
• Qualify electro-mechanical test tools and IQ/OQ.
• Perform hands-on testing and data analysis.
• Report defects and participate in root cause investigations.
• Develop verification protocols and oversee execution.
• Organize TRR readiness and documentation.
• Estimate task effort and communicate progress.
• Suggest improvements to SOPs and QA tools.

Skills

Test method development

Data analysis

Root cause analysis

Documentation

On-site work

Statistical methods

Education

Bachelor's degree in engineering

Master's degree in engineering

Tools

Jira

Minitab

Excel

Job description

Job Title: Systems Verification Engineer

Job Description

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, which includes 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. This includes installation and operational qualifications (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, 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.

Essential Skills

• Bachelor's degree in engineering (Mechanical or a related scientific/technical field is preferred).
• Familiarity with fluid and solid electro-mechanical, 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.

Additional Skills & Qualifications

• 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).