Fractional Wearables Lead

Job Description:

Fractional Wearables Lead

Location: Chicago, IL — Hybrid /
On-site for lab testing

Type: Fractional Contract / Contract-to-Hire

Target Start: Immediate — Q3/Q4 2026

To save everyone's time, we are only considering candidates who have personally shipped a regulated medical wearable (Class II or Class III) through FDA clearance or CE Mark approval and have hands-on experience authoring IEC 62366 usability engineering documentation.

General consumer product design, non-regulated wearables, or pure software/cloud experience will not meet the technical requirements of this clinical hardware role.

We are seeking a highly specialized Fractional Wearables Lead to own the physical patient-to-device interface for our next-generation EEG wearable patch.

This role will be critical to achieving medical-grade EEG signal integrity, reliable device performance, and patient comfort during continuous, multi-day wear.

• Electrode & Materials Engineering: Lead the selection and evaluation of medical-grade adhesives and wearable materials. Characterize and optimize skin-electrode impedance stability and develop solutions to minimize motion artifacts.
• Mechanical & Form Factor Design: Design, prototype, and iterate on wearable form factors, including patch and behind-the-ear configurations, while optimizing retention, comfort, and usability across diverse skin and hair types.
• Human Factors & Usability: Lead usability engineering activities in accordance with IEC 62366
  . Design intuitive donning and doffing workflows for patients and caregivers and author usability documentation for FDA and other regulatory submissions.
• Cross-Functional Collaboration: Work closely with electrical engineering, firmware, analog front-end, clinical, and regulatory teams. Support biocompatibility testing in accordance with ISO 10993 and contribute to regulatory submissions.
• Clinical Build Support: Support the assembly and testing of our first clinical-build wearable patch and contribute to the design of early clinical studies planned for late 2026.

Candidates must meet all of the following requirements:

• Regulated Medical Wearables: Personally shipped at least one regulated Class II or Class III medical wearable
  —such as a CGM, ECG/EEG patch, or smart hearable that successfully achieved FDA clearance or CE Mark approval
  .
• Hands-On Usability Engineering: Proven experience authoring IEC 62366 usability engineering files/documentation for an actual regulatory submission.
• Electrode & Adhesive Expertise: Deep technical expertise in skin-electrode interface physics, impedance characterization/testing, motion-artifact mitigation, and medical adhesive behavior.
• Hardware Engineering
  
  Experience:
  
  Hands-on experience with the physical design, testing, prototyping, and validation of medical wearables.
• Location & Availability: Ability to support hardware testing and collaborate with our Chicago-based engineering lab as needed.

This is a hands-on engineering role, not a high-level project management position. Candidates who do not meet the hard gatekeeper requirements above will not be considered.