Director of Hardware Engineering

A BIT ABOUT SIBEL HEALTH:

Sibel Health is a digital health company with a mission to deliver Better Health Data for All®. With headquarters in Chicago and an office in Seoul, we develop wireless wearable vital signs monitoring systems that combine advanced sensors, software, and cloud analytics. Our technologies are used in hospitals and remote settings around the world, with a particular focus on vulnerable populations such as pregnant persons and babies.

With multiple FDA clearances and strong partnerships across healthcare and global health organizations, we are growing our team of mission-driven professionals who believe technology can improve outcomes for the most vulnerable patients.

THE OPPORTUNITY:

We are looking for a Director of Hardware Engineering to lead the development of Sibel’s next-generation wireless wearable vital signs monitoring platforms. In this critical leadership role, you will directly manage a multidisciplinary team of 8 hardware engineers and lead concurrent medical device development programs from concept through production, ensuring high-quality execution within Sibel’s product development process and device quality system.

This role owns the hardware contribution to FDA submissions and global regulatory approvals in partnership with Regulatory Affairs and Quality Assurance, ensuring compliance with IEC 60601, IEC 62304, ISO 10993, ISO 13485, ISO 14971, and FDA 21 CFR Part 820. You will act as a key bridge between hardware, software, and manufacturing by partnering closely with the Director of Software Engineering and the Director of Manufacturing Operations to deliver integrated, production-ready solutions for hospital, research, and remote monitoring environments.

WHAT YOU WILL BE WORKING ON

• Lead, mentor and develop a team of 8+ hardware engineers (EE, ME, BME), providing regular coaching, performance feedback, and career development.
• Build a strong, mission-driven engineering culture that emphasizes ownership, design rigor, collaboration, and continuous improvement.
• Establish and cultivate best practices for design reviews, documentation, and lab practices with clear expectations for quality, schedule adherence, and technical excellence.

• Lead the complete hardware development lifecycle from requirements and architecture through design, verification/validation, design transfer, and sustaining efforts for multiple wearable vital signs monitoring products and accessories.
• Own architecture and requirements for wireless wearable sensors, patient monitors, and consumables, balancing power, size, RF performance, reliability, and cost.
• Ensure robust design controls and traceability (design inputs/outputs, DFMEA/PFMEA, V&V plans, DHF/DMR) and oversee EVT/DVT/PVT builds, hardware bring-up, failure analysis, and corrective actions with test, quality, and manufacturing.

• Lead concurrent product development initiatives, managing resources, timelines, and technical risk across platforms while maintaining high quality and compliance.
• Partner with Regulatory Affairs and Quality to define device classifications, support FDA 510(k) and other regulatory submissions, and respond to regulatory queries related to hardware design, verification, and risk management.
• Ensure designs meet medical device standards, including IEC 60601, IEC 62304, ISO 10993, ISO 13485, ISO 14971, and FDA 21 CFR Part 820.

• Partner with the Director of Software Engineering to tightly integrate hardware, embedded firmware, and cloud/mobile software, particularly for wireless communication, data integrity, and cybersecurity in vital signs monitoring.
• Partner with the Director of Manufacturing Operations to define manufacturing strategies, drive DFM/DFA/DFT/DFx into designs and enable smooth design transfer to contract manufacturers and in-house production.
• Collaborate with Clinical, Regulatory, Quality, Product, and Commercial teams to translate clinical and customer requirements into robust hardware architectures and product roadmaps.

• Lead design of low-profile, skin-contact wearable sensors (flex PCBs, biocompatible materials, adhesives, ingress protection) aligned with Sibel’s wireless vital signs monitoring portfolio.
• Oversee development of analog and digital front ends for cardiac and respiratory monitoring, temperature, motion, and other physiological signals, and guide RF/wireless design and validation (e.g., Bluetooth Low Energy) to ensure robust connectivity in hospital and remote settings.

• Own hardware readiness for manufacturing, including process validation, production test strategy, and line bring-up with global contract manufacturers.
• Drive cost reductions and yield improvements while maintaining safety, performance, and regulatory…