Mechanical Engineer

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.

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.

What you'll do

• 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.
• Design for the physics of small fluid volumes, where surface tension, capillarity, and wetting govern behavior — microliters to milliliters, larger than microfluidics.
• Design and implement temperature-control systems.
• 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.
• 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.
• Build in aseptic processing, cleanability, and ease of use from the start, including partnering on the instrument's user interface.
• Use rapid prototyping and benchtop breadboarding to prove out concepts quickly and cheaply before committing to tooling or automation.
• 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
• Design and conduct validation experiments; own design controls, verification, and validation to support CLIA compliance and our FDA and payer approval path.
• Develop and maintain SOPs, and document your methods, results, and design decisions to a rigorous, audit-ready standard.
• Support patent filings related to your work.
• Train staff on operating the instrument once built.

What you bring

• BS in bioengineering, mechanical engineering, or a related field, plus 3+ years of hands-on engineering experience.
• Experience and knowledge of how to automate a manual process
• Hands-on experience with pick-and-place, motion control, machine vision, and mechatronics.
• Experience and knowledge of modern manufacturing methods for rapid prototyping and low volume production for the consumables and building the instrument that handles them.
• Experience and knowledge of design for manufacture principles (injection molding, stamping, etc.)
• 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.
• Willing to work full time onsite in Houston.

Nice to have

• 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.

Details

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