Director, Device Engineering

Beacon Biosignals is on a mission to revolutionize precision medicine for the brain. We are the leading at‑home EEG platform supporting clinical development of novel therapeutics for neurological, psychiatric, and sleep disorders. Our FDA 510(k)-cleared Waveband EEG headband and AI algorithms enable quantitative biomarker discovery and implementation. Beacon’s Clinico‑EEG database contains EEG data from nearly 100,000 patients, and our cloud‑native analytics platform powers large‑scale RWD/RWE retrospective and predictive studies.

Beacon Biosignals is changing the way that patients are treated for any disorder that affects brain physiology.

As Director of Device Engineering, reporting to the VP of Device Engineering, you will lead and scale a multidisciplinary engineering team spanning hardware and systems engineering. This is both a technical and people leadership role, responsible for defining and executing Beacon’s device engineering strategy and ensuring operational excellence across the organization.

You will own the end‑to‑end lifecycle of our home sleep testing products, from concept and architecture through verification, regulatory submission, manufacturing transfer, commercialization, and sustaining engineering. You will ensure the delivery of safe, reliable, high‑quality medical devices that meet clinical needs, regulatory requirements, and business objectives. In addition, you will oversee ongoing product support and improvement efforts, including vendor and contract manufacturer management, production and post‑production issue resolution, yield improvement, and design enhancements to improve reliability, performance, and scalability.

You will partner closely with Beacon’s QA, RA, Clinical Operations, and Logistics functions to maintain rigorous design controls, disciplined risk management, and audit readiness aligned with applicable medical device regulations. As Beacon continues to grow, you will play a critical role in upholding the highest standards of safety, compliance, system integrity, and product excellence in Device Engineering.

This position is based in the Boston area to enable close partnership with our Boston‑based team.

• Ensures full compliance with Beacon’s QMS. Hardware development and sustaining activities consistently meet design control, documentation, and regulatory requirements, with audit‑ready processes and high‑quality deliverables.
• Owns the end‑to‑end device lifecycle. Oversees the complete Home Sleep Test device lifecycle from concept and development through verification, manufacturing transfer, launch, mass production and sustaining engineering, ensuring products meet regulatory standards, reliability targets, cost goals, and business objectives.
• Leads and expands a high‑performing device engineering team. Actively mentors and coaches engineers, strengthening technical depth in hardware design, systems integration, verification & validation, and regulated product development to elevate overall team capability.
• Provides strong technical leadership across development and manufacturing. Guides architectural decisions, risk management, and trade‑offs to support new product introduction, manufacturing scale‑up, and mass production readiness.
• Delivers rigorous design control execution. Leads the creation and review of design control artifacts to ensure regulatory compliance and clear technical alignment.
• Champions engineering excellence and product quality. Establishes and reinforces best practices in system design, technical decision‑making, and root cause analysis, balancing strategic oversight with hands‑on engagement when needed.
• Aligns engineering execution with company strategy. Partners with leadership to align device engineering priorities with company OKRs, while shaping long‑term product roadmaps and technical direction.

• Education:
  
  Bachelor’s degree in Engineering or a related technical field required; advanced degree (MS or PhD) preferred.
• Work Experience (post‑graduate): 10+ years of post‑graduate experience leading hardware or device engineering teams, with a demonstrated track record of delivering FDA‑ and/or…