Fractional Wearables Lead

Stealth Startup; Chicago (IL); Híbrido; USD 180.000 - 240.000; A tiempo parcial

Descripción de la vacante

Stealth Startup seeks a Fractional Wearables Lead to own the patient-to-device interface for a next‑gen EEG wearable patch. This hands-on role focuses on medical-grade signal integrity, comfort, and device reliability during multi-day wear.

Responsibilities include electrode/adhesive selection, form-factor iteration, usability design per IEC 62366, and cross-functional collaboration with Chicago lab teams. Immediate start for lab testing and regulatory readiness.

Formación

• Experience shipping regulated medical wearables (Class II/III) with FDA clearance or CE Mark.
• Hands-on IEC 62366 usability engineering documentation.
• Hardware wearables design, testing and validation.
• Ability to collaborate with a Chicago-based engineering lab.
• Regulatory submissions experience (FDA/ISO).

Responsabilidades

• Lead electrode and adhesive evaluation for medical-grade interfaces.
• Design and iterate wearable form factors for comfort and reliability.
• Lead usability activities per IEC 62366 and document workflows.
• Collaborate with electrical, firmware, clinical, and regulatory teams.
• Support clinical-build testing and early studies planned for late 2026.

Conocimientos

Electrode & Adhesives

Mechanical Design

Human Factors

Regulatory Submissions

Cross-Functional Collaboration

Descripción del empleo

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.

Role Overview

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.

Key Responsibilities

• 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.