Medical Device Testing Jobs in Austin, TX (NOW HIRING)

Position Purpose:

Are you ready to make a meaningful difference in public health and national security? Signature Science is seeking a highly motivated and skilled Systems Integration & Controls Engineer to join our dedicated team. This pivotal role offers you the opportunity to contribute directly to complex R&D initiatives safeguarding national defense and enhancing biological safety. Your primary focus will be serving as the master integrator for a novel, clinical-grade In Vitro Diagnostic (IVD) sample preparation and testing device. This device bridges the gap between physical hardware, biology, and data systems. In this role, you will act as a lead in system integration, orchestrating technical deliverables between internal mechanical engineers and external electrical engineering subcontractors, and ensuring the entire instrument functions seamlessly as a unified platform. Additionally, you will serve as a core engineering resource across the company, applying your skills to a diverse portfolio of broader systems engineering and hardware integration projects.

Essential Duties and Responsibilities:

• Act as a system integrator, ensuring flawless interoperability between prototype mechanical hardware, electrical architectures, fluidics, and control software.
•  Design and implement control architectures and automation strategies for prototype microfluidic and automated fluid-handling instruments, working closely with mechanical engineers and molecular biologists.
• Define, manage, and debug technical interfaces, communication protocols, and APIs between external electrical engineering subcontractor deliverables and internal system components.
• Integrate sensors, actuators, and other specialized equipment into both bespoke and pre-existing industrial or laboratory control architectures.
• Work with multidisciplinary teams including a Principal Investigator, Quality/PM lead, and bioinformaticians to develop rigorous testing procedures, system verification protocols, and quality control methods to ensure consistent device performance.
• Troubleshoot, debug, and solve complex electro-mechanical, fluidic, and system-level issues, utilizing industry best practices to analyze performance data.
•  Support broader company-wide systems engineering efforts, providing electrical, controls, and hardware integration expertise across various cross-functional project teams.
• Contribute to the development and maintenance of laboratory standard operating procedures (SOPs) and systems engineering documentation.
• Identify novel research directions, contribute to technical proposal efforts, and explore potential funding opportunities.
• Maintain accurate, detailed laboratory records and project documentation.
• Present research findings and engineering updates at internal technical reviews and external client meetings.

Required Knowledge, Skills & Abilities:

• Minimum 3–5 years of experience designing, integrating, testing, and troubleshooting control or system software strategies for prototype hardware, preferably related to microfluidics, lab-on-a-chip, or precision automated laboratory systems.
• Demonstrated experience acting as a system integrator or technical bridge across multidisciplinary teams (e.g., mechanical, electrical, software, and biological sciences).
• Proven ability to interface with, evaluate, and integrate hardware or electrical engineering deliverables provided by external subcontractors.
• Demonstrated experience using microcontrollers, single-board computers (e.g., Arduino, Raspberry Pi, or similar), or PLCs to control, script, and automate physical systems.
• Experience establishing and debugging serial and network communication protocols (e.g., I2C, SPI, UART, CAN, TCP/IP) for interfacing and data transfer.
• Familiarity with systems engineering principles, including the translation of P&ID documentation, functional requirements, and flow diagrams into robust control algorithms.
• Familiarity with sensors and actuators relevant to fluid handling and automation, including pressure sensors, flow sensors, valves, pumps, and temperature controllers.
• Ability to collaborate effectively within cross-functional teams, including mechanical engineers, chemists, molecular biologists, and software developers.
• Excellent troubleshooting, analytical, and detailed documentation skills for iterative prototyping, validation, and transfer to production.
• Experience using emerging AI tools or agentic AI systems to achieve specific objectives in an engineering or laboratory environment.
• Experience or willingness to participate in grant writing and technical report preparation.

Other Potential Relevant Experience:

• Familiarity with software development lifecycles within regulated environments, specifically medical device or IVD software design controls (IEC 62304 / ISO 14971).
• Experience establishing verification and validation (V&V) protocols intended for FDA or regulatory submissions.
• Proficiency with circuit design, schematic capture, PCB layout, and hands-on soldering and assembly skills to support the transition of R&D prototypes into robust systems.

Education/Experience:

• Bachelor's degree or higher in Systems Engineering, Mechatronics, Electrical Engineering, Controls Engineering, Biomedical Engineering, or a related discipline.

Certificates/Licenses:

• None required

Clearance:

• This position requires that the candidate be willing and able to complete a successful background screening for a security clearance. Candidates with an active security clearance will receive preference.

Supervisory Responsibilities:

• None

Working Conditions/ Equipment:

This is a full-time, fully on-site position. This position primarily operates during standard business hours, with occasional needs for extended workdays or weekend work to meet project timelines. A significant portion of this role (approximately 50%) involves hands-on laboratory work and benchtop engineering. You should be comfortable spending extended periods of time conducting hardware experiments and working at a computer. The role may also require occasional domestic travel for conferences, client meetings, or research-related travel. The ability to lift and carry light loads (under 25 lbs) without assistance is necessary.