Research And Development Engineer (Mechantronics)

About the company: EMPIRI is a Houston based cancer-diagnostics company. Our proprietary E-slice platform measures how a patient's tumor responds to specific drugs, on live tumor tissue. We're automating it into a benchtop instrument that will run as a laboratory-developed test in our CLIA lab and generate the data behind FDA and payer approval.

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The role: You'll be our primary in-house engineer, owning the design and build of the instrument end to end. The hard problems are primarily mechanical and involve fluid dynamics: handling and cutting small, delicate pieces of fresh tissue, and fluid in volumes where surface tension and wetting govern how it behaves; and doing it so the result is repeatable, aseptic, repeatable, and easy to use. You'll prove ideas out with fast, low-cost prototyping in our lab, then carry the design through into moderate-volume production. You'll own design controls, verification, and validation, and hand off UI, software, and larger fabrication to our engineering partners. You'll work directly with the CEO.

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What you'll do

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• Design, prototype, and refine precision mechanisms for handling and cutting small, delicate tissue samples (hundreds of micrometers to ~10 mm) — developing new methods as our assay evolves.
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• Design for the physics of small fluid volumes, where surface tension, capillarity, and wetting govern behavior — microliters to milliliters, larger than microfluidics.
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• Design and implement temperature-control systems.
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• Develop and build novel pick-and-place, motion control, and machine-vision feedback into a cohesive mechanical system — this is fundamentally a mechanical engineering problem.
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• Design single-use consumable components with DFM in mind, for both rapid prototyping and production quantities (100s–10k units); work with vendors on low-volume production tooling.
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• Build in aseptic processing, cleanability, and ease of use from the start, including partnering on the instrument's user interface.
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• Use rapid prototyping and benchtop breadboarding to prove out concepts quickly and cheaply before committing to tooling or automation.
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• Partner with a 3rd party engineering firm to take proven concepts into a fully realized, validated instrument, ready for use in the lab with live samples
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• Design and conduct validation experiments; own design controls, verification, and validation to support CLIA compliance and our FDA and payer approval path.
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• Develop and maintain SOPs, and document your methods, results, and design decisions to a rigorous, audit-ready standard.
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• Support patent filings related to your work.
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• Train staff on operating the instrument once built.
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What you bring

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• BS in bioengineering, mechanical engineering, or a related field, plus 3+ years of hands-on engineering experience.
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• Experience and knowledge of how to automate a manual process
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• Hands-on experience with pick-and-place, motion control, machine vision, and mechatronics.
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• Experience and knowledge of modern manufacturing methods for rapid prototyping and low volume production for the consumables and building the instrument that handles them.
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• Experience and knowledge of design for manufacture principles (injection molding, stamping, etc.)
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• Experience developing a regulated medical device or IVD under design controls (verification, validation, design history file) — or a strong record of building to rigorous, documented standards and readiness to own our design-control process.
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• Willing to live in Houston and work onsite, full-time.
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Nice to have

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• Some coding (Python / scripting, basic controls); machine-vision experience; design-for-manufacture (injection molding, machining); lab-automation or liquid-handler experience (e.g., Opentrons); comfort working hands-on in a wet lab / BSL-2 setting, or eagerness to learn it.
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Details

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• Onsite near the Texas Medical Center, Houston,
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• Full-time.
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• Position is open now
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• A small team and work that reaches cancer patients.
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