Head Of Device

Stealth Startup · Chicago, United States

Head of Device (Wearables)

Location: Chicago, IL

Employment Type: Contract-to-Hire / Fractional / Full-Time

About the Role

We are seeking an experienced Head of Device to lead the development of a next-generation wearable medical device designed for ambulatory EEG monitoring, seizure detection, and prediction in people with epilepsy.

The device combines discreet, adhesive-mounted EEG patches with machine-learning technology trained on clinical EEG data. The product is progressing toward FDA 510(k) clearance, with a phased regulatory strategy.

With electronics, firmware, and software development already underway, the primary focus of this role will be the physical device, including the electrode-skin interface, adhesive performance, comfort, mechanical engineering, industrial design, and human factors.

The successful candidate will own the overall device architecture and ensure that the physical product meets clinical, technical, usability, and regulatory requirements.

Key Responsibilities

1. System Requirements and Architecture

• Own system-level user needs, design inputs, and technical requirements for the wearable device.
• Translate system requirements into specifications for electronics, firmware, and software teams.
• Make key architectural decisions regarding form factor, patch size, electrode placement, battery, charging, enclosure, and mobile app connectivity.
• Serve as the final technical decision-maker across device engineering disciplines.

2. Electrode Interface and Wearability

• Lead electrode and medical adhesive selection, characterization, and performance evaluation.
• Optimize skin-electrode impedance, signal quality, wear duration, skin tolerance, and removal experience.
• Plan and conduct bench testing and on-body evaluations to validate device performance.
• Define electrode materials, plating, and geometry in collaboration with electrical engineering.

3. Mechanical Engineering, Industrial Design and Human Factors

• Lead mechanical engineering and industrial design from concept development through design for manufacturing.
• Oversee human factors activities, including use-related risk analysis, formative studies, and summative validation.
• Identify, engage, and manage external design and engineering firms.
• Ensure design partners deliver against established schedules, budgets, and quality standards.

4. Design Controls and Regulatory Compliance

• Own device-related design controls and design history documentation in collaboration with clinical, regulatory, and quality leadership.
• Drive verification planning for applicable medical device standards, including IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, ISO 10993, and IEC 62366-1.
• Support device readiness for clinical studies and feasibility evaluations with clinical partners.
• Ensure alignment with applicable ISO 13485 and FDA quality system requirements.

5. Team Leadership and Execution

• Lead the electrical engineering and firmware lead, with oversight of the embedded firmware team through that lead.
• Coordinate with software, machine-learning, clinical, regulatory, and quality teams.
• Develop the device roadmap, budget, and vendor strategy.
• Report progress, technical risks, and key decisions to executive leadership.

Required Qualifications

• 10+ years of experience in medical device development.
• Experience taking at least one body-worn medical device through FDA clearance (510(k) or De Novo) and into production.
• Strong hands-on expertise in mechanical engineering or industrial design for wearable devices.
• Working knowledge of skin-contact materials, medical adhesives, and wearable-device usability.
• Proven experience leading multidisciplinary teams across electrical engineering, firmware, and mechanical engineering.
• Experience managing design controls under ISO 13485 and applicable FDA quality system requirements.
• Experience leading human factors programs in accordance with IEC 62366-1.
• Demonstrated ability to manage external design and engineering partners against defined deliverables, timelines, budgets, and quality standards.
• Ability to operate effectively in a startup environment, make technical decisions with incomplete information, and drive practical experimentation.

Preferred Qualifications

• Experience with biopotential devices such as EEG, ECG, or EMG.
• Familiarity with dry electrodes, hydrogel electrodes, and multi-day wearable patches.
• Knowledge of ambulatory EEG standards, ACNS guidelines, or epilepsy monitoring units.
• Experience with low-power Bluetooth Low Energy (BLE) devices.
• Previous startup or first-device development experience.
• Experience scaling medical devices to contract manufacturing.

First 90-Day Priorities

Days 1–30

• Review existing hardware designs, system requirements, and test data.
• Meet engineering teams and clinical partners.
• Identify and assess the highest-priority technical risks.

Days 31–60

• Establish a system requirements baseline with requirements flowing down to electrical engineering and firmware.
• Scope and engage external mechanical engineering, industrial design, and human factors partners.
• Initiate electrode and adhesive characterization.

Days 61–90

• Deliver a device roadmap covering the next clinical study, including budget and vendor plans.
• Present initial electrode impedance and wear-time results.
• Recommend electrode spacing and placement for the next prototype build.

Engagement and Compensation

Flexible engagement options are available, including fractional consulting, contract-to-hire, and full-time employment for the right candidate. The initial engagement is expected to involve at least 20 hours per week, with the potential to transition to full-time as the program grows.

Compensation will combine cash and equity, scaled to the level of commitment.