Systems Test & Verification Engineer

VERO BIOTECH INC•Atlanta, GA

About The Position

At VERO Biotech, our mission is to improve the lives of patients by developing innovative technologies that support critical care and respiratory therapy through inhaled nitric oxide delivery in the acute care hospital setting or wherever nitric oxide treatment is needed. We strive to exceed customer expectations in terms of safety, efficacy, and value by focusing on the science, development, and commercialization of our innovations. POSITION SUMMARY The Systems Test & Verification Engineer will lead the development of test strategies, exploratory evaluation methods, and formal design verification activities from early concept development through submission readiness. This role partners with Systems Engineering to ensure system requirements are measurable, testable, and supported by objective evidence throughout product development.

Requirements

Bachelor’s degree in mechanical, Electrical, Biomedical Engineering or related technical field.
3+ years’ experience in design verification and test engineering within regulated medical device or complex electromechanical product development.
Hands-on experience authoring and executing DV protocols, test methods, reports, and acceptance criteria.
Hands on experience developing and qualifying test setups (fixtures, automation, data acquisition).
Strong technical skills in data analysis, signal measurement, instrumentation, and engineering test best practices.
Excellent communication skills with ability to clearly document technical results and collaborate with multidisciplinary teams.
Strong knowledge and Class II/III product experience of design controls, risk management, requirements management, and V&V.
Regulatory standard familiarity such as ISO 13485, ISO 14971, IEC 62304, etc)

Nice To Haves

Experience with respiratory devices, ventilators, or combination products.
Familiarity with formal design controls, DHF maintenance, and verification evidence requirements.
Experience with test automation frameworks and scripting (eg Python, LabVIEW) for data capture and analysis
Exposure to environmentally/accelerated test standards (EMC/ESD, thermal, humidity) and reliability testing.

Responsibilities

Develop structured exploration and characterization test plans with the subsystem leads to evaluating concept feasibility and system performance envelopes.
Design and implement prototype test setups and instrumentation for early hardware, firmware, and integrated system builds.
Generate data to inform architecture decisions, trade studies, and risk assessments.
Identify performance sensitivities, failure modes, and margin gaps during early integration.
Collaborate with Systems Engineering to refine measurable system requirements based on empirical data.
Develop design verification plans and protocols that map requirements to objective test methods with defined acceptance criteria.
Build and qualify test fixtures, instrumentation setups, and automated data capture necessary for repeatable and reliable execution.
Perform DV testing across mechanical, electrical, software/firmware, environmental, and system-level performance tests.
Support requirements-to-test evidence traceability, linking product requirements, risk controls, protocols, and DV reports.
Analyze verification data using rigorous statistical and engineering methods; document results with clarity, including deviation handling and root cause insights.
Ensure DV artifacts align with applicable regulatory standards (e.g., FDA 21 CFR 820, ISO 13485) and established design control practices.
Partner with Quality Engineering to support audit readiness and contribute to the Design History File (DHF).
Facilitate robust technical communication with R&D, quality, and manufacturing to close gaps between design intent and verified performance.
Support V&V planning across product lifecycle stages, including design transfers and post-development updates.
Define measurement of accuracy requirements and validate test system capability.
Develop prototype inspection criteria and inspection procedures for engineering and pilot builds.
Identify critical to function characteristics and partner with Operations to inform early process controls.
Support tolerance stack validation and manufacturing feasibility assessments.