Sr. Validation & Verification Engineer

Sr. Verification & Validation Engineer (onsite)
Salt Lake City, UT
Contract to hire
Pay: $50-$65/hr

Job Description:

We are looking for a Senior Verification and Validation (V&V) Engineer to lead the development and execution of our testing strategy across hardware, embedded software, and clinical software systems. In our fast-paced startup environment, this role will be critical in planning, executing, and documenting V&V activities to ensure the safety, effectiveness, and regulatory compliance of our integrated medical systems.

The ideal candidate will work closely with cross-functional teams-including engineering, product management, software development, and regulatory affairs-to verify signal integrity, validate algorithms, and ensure end-to-end system performance in real-world clinical scenarios.

Responsibilities:

• Lead the development and ownership of the V&V strategy across the full system stack, including EEG acquisition hardware, embedded firmware, software applications, and cloud services.
• Design, write, and execute both manual and automated test protocols for system-level and component-level verification and validation.
• Apply experience with V&V protocol development under formal design controls and within a quality management system (QMS).
• Partner with software, data science, and product teams to translate clinical use cases into actionable and realistic test scenarios.
• Support the creation and execution of validation tests aligned with intended use.
• Ensure adherence to regulatory standards, including FDA design controls, IEC 62304, ISO 13485, IEC 60601, and ISO 14971.
• Develop and maintain test infrastructure, including test setups, simulators, and automation tools.
• Establish and manage traceability between requirements and test cases using tools such as Jira, Jama, or equivalent.
• Contribute to regulatory submissions and maintain design history file (DHF) documentation.
• Play an active role in shaping V&V best practices and company culture as the organization scales.

Required Experience:

• Bachelor's or Master's degree in Mechanical, Electrical, Biomedical, Computer, Software Engineering, or a related discipline.
• 5+ years of direct experience in verification and validation (V&V) of medical devices.
• Proven ability to verify complex systems involving hardware, firmware, and cloud-based or desktop software components.
• Skilled in producing clear, well-structured documentation that complies with FDA and ISO standards.
• Hands-on, practical approach-equally comfortable troubleshooting in the lab with oscilloscopes or writing Python test scripts.
• Strong commitment to quality and excellence in fast-paced, mission-driven environments.

Preferred Skills:

• Experience working in clinical settings (e.g., ICU, OR) or collaborating with clinicians to gather requirements and user feedback.
• Knowledge of cybersecurity testing, wireless medical technologies, or mobile health applications.
• Understanding of neurological signals such as EEG or EMG, and experience testing systems that acquire and process these signals.
• Previous involvement in supporting 510(k) regulatory submissions or FDA pre-submission meetings.

Welcome to ConsultNet and the family of companies, Tekne, SaltClick, TechBridge, and OmniMedia. As a premier national provider of technology talent and solutions, our expertise spans across project services, contract-to-hire, direct placement, and managed services both onshore and nearshore.

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