Director of Hardware Engineering
Posted on February 22, 2026 (3 months ago)
This job post is archived - the company is no longer hiring for this position.
Check out other job posts of this company here!A BIT ABOUT SIBEL HEALTH:
Sibel Health is a digital health company headquartered in Chicago with an office in Seoul. They develop wireless wearable vital signs monitoring systems combining advanced sensors, software, and cloud analytics, used in hospitals and remote settings with a focus on vulnerable populations. The company holds multiple FDA clearances and partners with healthcare and global health organizations.
THE OPPORTUNITY:
We are hiring a Director of Hardware Engineering to lead development of Sibel’s next-generation wireless wearable vital signs monitoring platforms. This leadership role will directly manage a multidisciplinary hardware team and drive multiple medical device development programs from concept through production within the company’s product development process and device quality system.
RESPONSIBILITIES:
- Lead, mentor, and develop a team of 8+ hardware engineers (EE, ME, BME), providing coaching, performance feedback, and career development.
- Establish engineering best practices for design reviews, documentation, and lab practices focused on quality and schedule adherence.
- Own end-to-end hardware development from requirements and architecture through design, verification/validation, design transfer, and sustaining engineering for wearable sensors and accessories.
- Define 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, bring-up, failure analysis, and corrective actions.
- Lead concurrent product development initiatives, managing resources, timelines, and technical risk across platforms.
- Partner with Regulatory Affairs and Quality to support FDA 510(k) and other regulatory submissions and ensure compliance with medical device standards.
- Collaborate closely with software and manufacturing leaders to deliver integrated, production-ready solutions and enable smooth design transfer to contract manufacturers.
- Drive manufacturing readiness, process validation, production test strategy, cost reduction, yield improvement, and sustaining engineering including ECO/DCO and obsolescence management.
TECHNOLOGY FOCUS:
- Design of low-profile, skin-contact wearable sensors (flex PCBs, biocompatible materials, adhesives, ingress protection).
- Analog and digital front ends for cardiac and respiratory monitoring, temperature, motion, and other physiological signals.
- RF/wireless design and validation (e.g., Bluetooth Low Energy) for robust connectivity in hospital and remote settings.
REQUIREMENTS / ABOUT YOU:
- Bachelor’s or Master’s in Electrical Engineering, Computer Engineering, or a closely related field.
- 10+ years in hardware/electromechanical engineering for medical devices or regulated healthcare technology with a track record of bringing electrotechnical medical devices from concept to production.
- 5+ years of leadership experience managing and mentoring hardware engineering teams of 8+ engineers.
- Deep expertise in embedded systems, low-noise analog front ends, power management, and RF/wireless integration for wearable or portable products.
- Hands-on leadership with medical device QMS, design controls, risk management, verification/validation, and design transfer.
- Practical experience with medical device standards and regulations (IEC 60601, IEC 62304, ISO 13485, FDA 21 CFR Part 820).
- Experience with document control and eQMS, DHF/DMR ownership, and ECO/DCO processes.
- Ability to manage multiple concurrent development pipelines and work cross-functionally in a fast-paced startup environment.
NICE TO HAVE:
- Experience leading Class II or Class III devices through FDA submissions and EU MDR or other international approvals.
- Experience developing wireless wearable or sensor-based vital signs monitoring devices.
- Experience with global contract manufacturers and scaling production for high-volume wearables or med‑IoT devices.
- Familiarity with biocompatible materials, skin-contact adhesives, and mechanical design for flexible wearables.
- Comfort with lab automation and data analysis tools (e.g., Python, National Instruments) to accelerate verification and manufacturing tests.
BENEFITS:
- Medical, dental, vision, life, and disability insurance.
- "Take as much time as you need" time-off policy.
- Simple IRA plan with employer matching.
- Company-sponsored events and lunches.
- Stipend for professional development.
EEO:
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.
How to apply
To apply for this role, click the Apply button on the LinkedIn job page or submit your application through LinkedIn for the posting at: https://www.linkedin.com/jobs/view/director-of-hardware-engineering-at-sibel-health-4366931112
Notes
You may be asked to provide a resume and additional details about your experience in medical device hardware and regulated product development during the LinkedIn application process.