Validation Engineer

Position Summary:

The Senior Systems Test Engineer will support the development of medical devices through execution of system-level verification and validation activities. This role will focus primarily 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.

The ideal candidate will have experience in medical device product development, systems testing, requirements management, and cross-functional collaboration.

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 (Knowledge, Skills & Abilities): 

Minimum

·         Bachelor of Science in Engineering, preferably Systems, Biomedical, EE, or ME.

·         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.

Preferred:

·         Graduate degree in Engineering (Biomedical, EE, ME or Systems Engineering) or another scientific discipline.

·         5 years of research and development experience

·         3 years 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.