Head of Design

Sibel Health | Chicago, IL

About Sibel Health

With headquarters based in Chicago, Illinois and an international office in Seoul, South Korea, Sibel Health is an award-winning digital health startup with a mission to deliver Better Health Data for All®. We were founded with a specific focus on our most vulnerable patients—pregnant persons and babies where we believe wireless monitoring has the potential to do the most good worldwide. We achieve this by providing a complete monitoring solution of advanced wireless wearables, best in class software, and novel AI/ML algorithms all linked to the cloud. To date, we've launched our technologies in 25 countries from the most advanced hospitals in the world to the most resource constrained locations. We work with some of the most respected healthcare organizations from major philanthropies to large medical technology and pharmaceutical companies. With numerous FDA clearances and a recently completed fundraising round, we are poised for growth and expansion. We are seeking mission-driven individuals with a strong sense of purpose who believe that technology can improve the lives of our most vulnerable patients.

The Opportunity

Sibel Health Inc. is seeking a Head of Design to perform the following duties:

• Maintain a consistent brand identity and visual design language across all company products and interfaces;
• Direct design activities to follow regulatory standards, including ISO 13485, IEC 62366, ISO 14971:2019, and FDA Human Factors Engineering Guidance;
• Prepare documentation to support regulatory submissions, including FDA 510(k) and CE MDR filings, human factors reports, and product risk analyses;
• Implement and maintain design processes, methods, and workflows to support efficient and compliant wearable medical device development;
• Collaborate with regulatory and quality teams to ensure human factors engineering documentation meets submission requirements;
• Ensure all design processes comply with occupational safety, environmental, and manufacturing regulations;
• Collaborate with engineering, product development, clinical, and manufacturing teams to incorporate user needs, technical feasibility, and manufacturing considerations;
• Support integration of industrial design and UI/UX principles to optimize product usability, safety, and performance;
• Oversee usability testing, iterative prototyping, and evaluations to confirm product design effectiveness and safety;
• Supervise a multidisciplinary design team, including product designers, graphic designers, and digital interface designers, overseeing task assignments, workload planning, mentorship, and performance tracking;
• Manage administrative functions of the design team, including procurement requests, vendor coordination, and departmental reporting; and
• Monitor and analyze industry trends, competitive products, and emerging technologies to drive design innovation and maintain awareness of best practices.

Requirements

This position requires a Master's Degree in Human Centered Design and Engineering, Industrial Design, or closely related, plus 9 months of experience as Medical Device Designer or closely related in the design and development of wearable medical devices in compliance with ISO 13485, ISO 62366, and FDA Human Factors and Usability Engineering Guidance for Medical Devices.

Salary & Benefits

$104,000/yr - $170,000/yr + Paid Time Off, Medical Insurance, Dental Insurance, Disability Insurance, Life Insurance, and Retirement Plan

If interested and qualified, please forward your resume to the following for consideration:

Sibel Health Inc.

Attn: HR (Include Ref#: 2621)

2017 N Mendell St., Suite 2SE

Chicago, IL 60614

Email: hr@sibelhealth.com