Lead Hardware & Systems Engineer (Biomedical)

About Yuthera
Yuthera is building the world's first uterine health intelligence platform — a wireless Y-shaped wearable patch that delivers precision neuromodulation patch, combined with a companion AI app that continuously monitors uterine health and personalizes treatment. Our beta study (n=35, p<0.001) demonstrated 84.4% pain reduction in 30 minutes. We have zero adverse events, 94% user satisfaction, and an active regulatory pathway in both the UAE (MOHAP) and UK/EU (CE Mark). We are pre-seed stage, building the commercial product, and looking for exceptional engineers who want to build something that matters.

The Role
This is Yuthera's first dedicated hardware hire and one of the most consequential roles in the company. You will own the end-to-end engineering of the Yuthera Patch, from flexible electrode substrate design through signal generation circuitry, firmware, biosensor integration, wireless communication, and regulatory technical documentation. You are not building a consumer gadget. You are building a Class IIa active medical device that will go through CE Mark and MOHAP approval, be worn on human skin, and used by women in significant pain. The bar for quality, safety, and rigor is correspondingly high.

Why this role is unusually significant

The YU Patch beta study proved the therapy works - 84.4% pain reduction is not a coincidence or a small effect. What we are now building is the commercially manufacturable, wireless, regulatory-compliant version of that device. The engineer who leads this will own the translation from a validated therapeutic mechanism into a product that thousands of women will use. That is a rare opportunity. The IP you create will be core to the company and your contribution will be visible in every investor conversation, every clinical study, and every regulatory submission we make.

What You Will Work On

1. Wearable Patch Hardware
   • Design and engineer a flexible, body-worn medical-grade patch in compliance with applicable biocompatibility and electrical safety standards
   • Develop the electrode array and stimulation delivery system, optimizing signal parameters for therapeutic efficacy and user comfort
   • Integrate wireless communication, power management, and charging systems into a discreet wearable form factor
   • Ensure IPX-rated durability and reliability for daily wearable use
   • Wireless communication: Bluetooth Low Energy (BLE) stack connecting patch to companion app; reliable pairing, session management, real-time intensity control
   • IPX4 minimum waterproofing: robust sealing for daily-wear activities

   1. Biosensor Integration • Integrate a multi-modal physiological sensing layer into the wearable device for continuous health monitoring • Solve the signal integrity challenges inherent in combining therapeutic stimulation with concurrent sensing on a shared hardware platform • Develop robust signal processing to produce clinically reliable data from an ambulatory wearable environment • Ensure sensor data quality meets the standards required for the AI pattern analysis and clinical escalation functions downstream
   2. Firmware and Embedded Software • Write and own all embedded firmware for the device: power management, therapeutic protocol execution, sensor data acquisition, and wireless communication • Develop and maintain software lifecycle documentation compliant with IEC 62304 for medical device software • Over-the-air (OTA) firmware update capability • Implement safety-critical behaviours appropriate for a Class IIa active medical device worn on skin
   3. Regulatory Technical Documentation • Build and maintain the technical file for CE Mark (EU MDR 2017/745) and MOHAP UAE regulatory submissions • Own the risk management file per ISO 14971 throughout the product development lifecycle • Electromagnetic compatibility testing preparation per IEC 60601-1-2 • Biocompatibility testing protocol and pre-screen per ISO 10993 series • Electrical safety verification per IEC 60601-1 • Usability engineering file per IEC 62366-1

What We Need From You

Essential
• 5+ years of hardware engineering experience with at least 2 years on a wearable, implantable, or body-worn device
• Direct experience taking a medical or consumer health device through a regulatory submission (FDA 510(k), CE Mark, TGA, or equivalent) — you must have navigated this process, not just been adjacent to it
• Hands-on PCB design, component selection, and schematic capture (Altium, KiCad, or equivalent)
• Embedded C/C++ firmware development for low-power microcontrollers with BLE
• Experience with BLE stack implementation and wireless medical device communication
• Working knowledge of IEC 60601-1 and ISO 14971 — you should be able to read a risk management file and know what is missing
• Comfort working without a large team: you will be hands-on from day one, not managing others who do the work

Strongly Preferred
• Experience with flexible electronics, soft substrates, or skin-contact electrode systems
• Biosensor integration experience — physiological sensing on a wearable or body-worn device
• TENS, neuromodulation, or electrotherapy device development background
• IEC 62304 software lifecycle documentation for Class B or Class C embedded medical software
• Knowledge of UK, UAE and EU medical device registration frameworks
• Experience at a startup or early-stage MedTech company where you owned the full stack

What You Are Like
• You think in first principles about electrical safety — not because you are told to, but because you understand what it means when a device is worn on skin
• You are comfortable with ambiguity and can make sound engineering decisions with incomplete information
• You document as you build. Regulatory documentation is not an afterthought for you
• You can communicate technical constraints to a clinical and product team without losing them
• You take ownership of outcomes, not just tasks

Role Context and Compensation Location

Location: Fully Remote

Reporting to: CEO

Type: Part-time to transition to Full-time post-funding
Start: Immediate
Salary: Equity ONLY (Salary post-funding)

A note on stage

Yuthera is pre-seed. This means the engineering budget is lean, the team is small, and the impact of what you build is immediate and visible. It also means the equity allocation is meaningful, the problem is genuinely important, and the work will be yours in a way that is rarely possible at a larger company. We are not looking for someone who needs a large team around them to function. We are looking for someone who prefers it this way.

To Apply
Send your CV and a short note (200 words or fewer) on the most technically challenging medical or health device problem you have solved to [email protected]. Applications without the short note will not be reviewed.