Systems/Verification & Validation Engineer

RbM Services•Oak Ridge, TN

14h

About The Position

As a Systems/Verification & Validation Engineer, you will bridge design innovation and high-quality production, supporting the cross-functional transfer of complex medical devices from the legal Device Manufacturer to the primary manufacturing facility. You will develop a deep understanding of device intended use, system and subsystem technical specifications, and theory of operation, serving as a technical anchor for verification, validation, and ongoing operational support. The role includes preparing and executing verification and validation plans and tests, developing and validating manufacturing test fixtures and procedures, improving product reliability and performance, and supporting quality investigations and component alternatives. You will also serve as a product subject matter expert for manufacturing and field service teams and create technical service documentation.

Requirements

Bachelor’s degree in Biomedical, Electrical, or Computer Engineering.
2–3 years of engineering experience in medical device design, test engineering, or manufacturing.
Proven experience executing software and electromechanical system-level verification and validation.
Hands-on ability to design, assemble, and troubleshoot electromechanical circuits and systems.
Ability to conceptualize and develop automated test fixtures.
Ability to interpret international or industry regulatory standards and apply technical requirements to product design and testing.
Proficiency with Microsoft Office Suite.
Demonstrated ability to manage multiple engineering assignments simultaneously in a structured environment.

Nice To Haves

3 or more years of experience taking complex electromechanical products from initial design concept through full manufacturing transfer.
Advanced proficiency with laboratory test equipment, including DMMs, oscilloscopes, logic analyzers, and spectrum analyzers, to troubleshoot systems to the component level.
Firm understanding of the standard engineering design process.
Basic understanding of the medical device product development lifecycle, including design controls and risk management.
Familiarity with specialized electrical and medical components, including Photomultiplier Tubes (PMTs), detection systems, motor controllers, stepper drives, X-ray tubes, and high-voltage generators.
Proactive, hands-on approach and enjoyment of building prototypes, troubleshooting hardware, and performing rigorous laboratory testing.
Strong analytical and problem-solving skills and adaptability in a fast-paced team environment.

Responsibilities

Provide technical feedback during design reviews and analyze requirements to develop test protocols and comprehensive verification and validation plans for systems and subsystems.
Track, manage, and execute verification and validation testing for engineering design changes before production implementation.
Conceptualize, develop, and validate test fixtures for subassembly verification before system integration.
Develop, document, and validate end-to-end system testing methodologies and assembly procedures.
Monitor and investigate product performance and real-world reliability metrics, and develop effective solutions.
Identify product optimization opportunities and lead the design and implementation of improvements.
Evaluate and disposition non-conforming products with cross-functional teams.
Collaborate on system- and subsystem-level root-cause investigations and establish preventative mitigations.
Source and validate alternate mechanical or electrical components to address end-of-life supply constraints.
Become a subject matter expert on product technologies and provide technical guidance to the manufacturing floor.
Author and maintain technical service guides and user manuals.
Provide high-tier troubleshooting support to field service staff during complex field events.