Systems Engineer

Our client PURioLABS is looking for a R&D Systems Engineer. See details below

About Us

PURioLABS is a growing medical device research and development company pioneering innovation in infection prevention. Our small team of healthcare and engineering professionals is committed to transforming cutting-edge research into impactful health technologies. We develop novel disinfection solutions that support healthcare providers improve patient outcomes and

enhance quality of life.

Our company created its first novel disinfection cabinet in the early days of COVID-19 pandemic and placed several units around the U.S. and pursued an FDA emergency use authorization. As we developed three more iterations of the cabinet and had completed successful 3rd party laboratory studies the pandemic ended and the EUA opportunity ceased. However the U.S. Army liked what we had created and asked us to create a solution for the U.S. military mobile and stationary medical units sterilizing a variety of sensitive medical devices. The Defense Health Agency funded a Phase I project which resulted in the smaller cabinet. A Phase II

project was again funded to advance the science and create a next-generation design shown as a CAD rendering. Due to great progress in the Phase II DHA has funded a Phase II project to complete the final design of the PURitALL Sterilizer and ready it for FDA clearance. This funding provides PURioLABS with a 24 month financial runway and an incredible opportunity to create wealth for our team members and change the world with our novel sterilization technology. We intend to demonstrate the efficacy and commercial viability and then sell or license the product to other medical device OEMs. We have 5 granted patents and 2 pending. PURioLABS has other products in the queue to create as well.

Position Overview

We are seeking a highly motivated and creative Research and Development Systems

Engineer with a solid foundation in mechanical engineering and a passion for experimentation

and problem-solving. This role centers on thedesign rapid prototyping and experimental testingof advanced mechanical systems that involveelectronic controls fluidics

hydrodynamics multiphase flows and thermodynamics.

At PURioLABS we prioritize innovation and flexibility. The members of our team work in a collaborative interdisciplinary environment with leaders in engineering medicine and science. You will have both the freedom and support to drive the direction of your workand the opportunity to shape technologies that deliver real clinical impact.

Key Responsibilities

• Coordinate the engineering projects and progress between our internal design efforts and those of our external design partners.
• Design and develop innovative mechanical components and systems for early-stage medical devices beginning with our advanced design of the current PURitALL disinfection cabinet which will receive a significant design update and be further prototyped in 2026 on a path toward FDA 510K clearance for a Class II device.
• Build and iterate functional prototypes using rapid prototyping tools (e.g. complex sourcing 3D printing CNC laser cutting all outsourced)
• Plan and conduct experiments to evaluate system performance in real-world and simulated conditions
• Analyze results troubleshoot system performance and refine designs accordingly
• Collaborate with cross-functional teams including biomedical engineers clinicians and regulatory professionals
• Clearly document engineering processes design decisions and experimental outcomes
• Manage configurations design control and signature approvals of adoptions and changes

Qualifications

Required:

• B.S. or M.S. in Mechanical Engineering Bioengineering or a related field
• Proficiency with CAD software (e.g. SolidWorks Fusion 360) and hands-on prototyping
• Strong understanding of fluid mechanics thermodynamics and/or multiphase systems
• Basic understanding of computer and electronically controlled machine engineering
• Basic understanding of common regulatory requirements for machine/user safety
• Excellent analytical experimental and troubleshooting skills
• Comfort working in a fast-paced iterative R&D environment often self-directed

Preferred:

• Experience in the medical device industry or translational research
• Familiarity with FDA or ISO standards relevant to medical devices
• Exposure to simulation tools (e.g. CFD FEA) for system modeling and analysis
• Experience working in microbiology lab environments