Sibel Health · 14 hours ago
Director of Hardware Engineering
Chicago, IL
Full-time
Onsite
Director/Executive
$160K/yr - $205K/yr
10+ years expSibel Health is a digital health company focused on delivering better health data through innovative monitoring solutions. They are seeking a Director of Hardware Engineering to lead the development of next-generation wireless wearable vital signs monitoring platforms, managing a team of engineers and ensuring compliance with medical device standards and regulations.
Artificial Intelligence (AI)Health CareMedicalMedical Device
Responsibilities
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 compliance; support change control (ECO/DCO), component qualifications, obsolescence management, post-market investigations, CAPAs, and continuous improvement across the hardware portfolio
Qualification
Required
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
Preferred
Experience leading Class II or Class III medical devices through FDA submissions (e.g., 510(k)) and EU MDR or other international regulatory approvals
Demonstrated experience developing wireless wearable or sensor-based medical devices involving vital signs monitoring (e.g., 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 (e.g., flex PCBs, elastomers, injection-molded and overmolded components)
Comfort with lab automation and data analysis tools (e.g., 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.
Company
Sibel Health
Sibel Health is a medical technology company that provides wireless vital signs monitoring and data integration.
51-200 employees
H1B Sponsorship
Sibel Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (8)
2023 (3)
Funding
Current Stage
Growth StageTotal Funding
$92.26MKey Investors
U.S. Food and Drug AdministrationSteele Foundation for HopeBill & Melinda Gates Foundation
2025-12-09Grant· $0.5M
2025-09-30Series C· $9M
2025-03-20Series C· $30M
Leadership Team
Steve Xu
Chief Executive Officer
Recent News
vcnewsdaily.com
2025-10-15
2025-10-15
Company data provided by crunchbase