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: Team Leadership & Engineering Team Lead

• 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.

End-to-End Hardware Development & Design Controls

• 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.

Multi-Program Ownership & Regulatory Submissions

• 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.

Cross-Functional Collaboration with Software & Manufacturing

• 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.

Wireless Wearable & Vital Signs Monitoring Technology

• 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 (eg, Bluetooth Low Energy) to ensure robust connectivity in hospital and remote settings.

Manufacturing Readiness & Sustaining Engineering

• 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 compliance; support change control (ECO/DCO), component qualifications, obsolescence management, post-market investigations, CAPAs, and continuous improvement across the hardware portfolio.

ABOUT YOU:

• Bachelor's or Master's degree in Electrical Engineering, Computer Engineering, or a closely related field.
• 10+ years of experience in hardware/electromechanical engineering for medical devices or highly regulated healthcare technology, with a proven track record of bringing electrotechnical medical devices from concept to production.
• 5+ years of leadership experience managing and mentoring hardware engineering teams of 8 or more engineers.
• Deep expertise in electrical engineering for medical devices, including Embedded systems, low-noise analog front ends, power management, and RF/wireless integration for wearable or portable products.
• Hands-on leadership of product development under a medical device QMS, including design controls, risk management, verification/validation, and design transfer.
• Practical, applied experience with core medical device standards and regulations, including IEC 60601, IEC 62304, ISO 13485, and FDA 21 CFR Part 820.
• Proven experience with document control and quality systems (eQMS), including DHF/DMR ownership, ECO/DCO processes, and strong documentation practices.
• Demonstrated ability to manage multiple concurrent product development pipelines, prioritize effectively, and balance technical risk, resources, and schedule.
• Strong cross-functional skills and emotional intelligence; comfortable working with engineering, manufacturing, clinical, regulatory, quality, and commercial stakeholders.
• Ability to work in a fast-paced startup environment and willing to be hands-on in the lab and on the manufacturing floor when needed.

NICE TO HAVE:

• Experience leading Class?II or Class?III medical devices through FDA submissions (eg, 510(k) and EU MDR or other international regulatory approvals.
• Demonstrated experience developing wireless wearable or sensor-based medical devices involving vital signs monitoring (eg, cardiorespiratory, ECG, respiratory effort, temperature, motion).
• Experience working with global contract manufacturers (US, Asia, or other regions) and scaling production for high-volume wearable or med-IoT devices.
• Familiarity with biocompatible materials, skin-contact adhesives, and mechanical design for flexible wearables (eg, flex PCBs, elastomers, injection-molded and overmolded components).
• Comfort with lab automation and data analysis tools (eg, Python, National Instruments) to accelerate verification, characterization, and manufacturing tests.

BENEFITS:

• Medical, dental, vision, life, and disability insurance.
• "Take as much time as you need" policy.
• Simple IRA plan with employer matching.
• Company sponsored events and lunches.
• Stipend for professional development.
• Opportunity to be part of a dedicated and driven team that is here to disrupt and revolutionize wireless monitoring.

Sibel Health Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.