Senior System Engineer

Pentangle Tech Services | P5 Group; Eden Prairie (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Pentangle Tech Services | P5 Group seeks a Senior Systems Test Engineer to drive verification and validation for medical device systems. You will plan tests, develop protocols, execute tests, analyze data, and document results to support compliance and product quality.

You will also manage requirements traceability, support risk management activities, and collaborate across systems, software, electrical, mechanical, quality, and regulatory teams.

Qualifications

• Bachelor of Science in Engineering.
• 5+ years of engineering experience.
• Experience developing and executing verification and validation protocols.
• Experience with requirements management and traceability.
• Familiarity with Jama or similar tools.
• Strong systems engineering knowledge and product development processes.
• Strong writing, documentation, and communication skills.
• Ability to work independently and manage multiple assignments.
• Experience supporting requirements development, verification planning, and traceability.
• Experience with risk management and systems engineering processes.

Responsibilities

• Develop and execute verification and validation test protocols for medical device systems.
• Document test results and generate verification and validation reports.
• Support development and review of system requirements to ensure completeness, clarity, and testability.
• Maintain requirements traceability and verification records using Jama.
• Support risk management and verification activities associated with product requirements.
• Perform root cause investigation and troubleshooting of test failures.
• Collaborate with systems, software, electrical, mechanical, quality, and regulatory teams.
• Participate in design reviews and product development activities.
• Ensure work complies with quality system and regulatory requirements.

Skills

Systems Engineering

Test Planning

Verification

Requirements

Jama

Documentation

Regulatory

Collaboration

Independent Work

Root Cause Analysis

Risk Management

Product Lifecycle

Education

Bachelor of Science in Engineering

Tools

Jama

Job description

Location: Eden Prairie, MN – Local Candidates Only

Position Summary

The Senior Systems Test Engineer will support the development of medical devices through execution of system-level verification and validation activities. The role will focus on test planning, protocol development, test execution, data analysis, and documentation. The engineer will also support requirements management activities, including requirements review, traceability, and verification planning using Jama.

Primary Duties and Responsibilities

• Develop and execute verification and validation test protocols for medical device systems.
• Document test results and generate verification and validation reports.
• Support development and review of system requirements to ensure completeness, clarity, and testability.
• Maintain requirements traceability and verification records using Jama.
• Support risk management and verification activities associated with product requirements.
• Perform root cause investigation and troubleshooting of test failures.
• Collaborate with systems, software, electrical, mechanical, quality, and regulatory team members.
• Participate in design reviews and product development activities.
• Ensure work is completed in compliance with applicable quality system and regulatory requirements.

Qualifications

• Bachelor of Science in Engineering, preferably Systems, Biomedical, Electrical Engineering, or Mechanical Engineering.
• 5+ years of engineering experience.
• Experience developing and executing verification and validation protocols.
• Experience with requirements management and traceability.
• Familiarity with Jama or similar requirements management tools.
• Working knowledge of systems engineering principles and product development processes.
• Strong technical writing, documentation, and communication skills.
• Ability to work independently and manage multiple assignments.
• Experience supporting requirements development, verification planning, and traceability throughout the product lifecycle.
• Experience with risk management and systems engineering processes.

Preferred Qualifications

• Graduate degree in Engineering (Biomedical, EE, ME, or Systems Engineering) or another scientific discipline.
• 5+ years of research and development experience.
• 3+ years of new product development in a systems engineering role.