Systems Test Engineer

The Senior Systems Test Engineer will support the development of medical devices through the execution of system-level verification and validation activities. This role primarily focuses on test planning, protocol development, test execution, data analysis, and documentation. Additionally, the engineer will support requirements management activities, including requirements review, traceability, and verification planning. 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.
• 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 standards.

• Bachelor of Science in Engineering, preferably Systems, Biomedical, Electrical, or Mechanical Engineering.
• 5+ years of engineering experience.
• Experience developing and executing verification and validation protocols.
• Experience with requirements management and traceability.
• Familiarity with 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., * Graduate degree in Engineering (Biomedical, Electrical, Mechanical, or Systems Engineering) or another scientific discipline.
• 5+ years of research and development experience.
• 3+ years in new product development in a system engineering role.
• Experience supporting requirements development, verification planning, and traceability throughout the product lifecycle.
• Experience with risk management and systems engineering processes.

Work Environment

The work environment is focused on engineering activities related to medical device development. The position involves collaboration with cross-functional teams, including systems, software, electrical, mechanical, quality, and regulatory. The role requires adherence to quality systems and regulatory standards, ensuring high standards of compliance and performance. Job Type & Location, Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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