Director, Device Engineering

Beacon Biosignals•Boston, MA

9h•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering or a related technical field required
10+ years of post-graduate experience leading hardware or device engineering teams, with a demonstrated track record of delivering FDA- and/or CE-regulated products from concept through commercialization.
At least 5 years of direct people management experience with increasing scope and responsibility, including hiring, performance management, and building high-performing engineering teams.
Deep technical expertise in hardware and systems engineering: Strong foundation in wearable devices and embedded systems, with the ability to drive architectural decisions, evaluate technical trade-offs, and guide complex cross-disciplinary problem-solving.
Fluency in medical device regulations and quality systems: Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and design control best practices, with experience producing audit-ready documentation and leading compliant development processes.
End-to-end product lifecycle and manufacturing experience: Hands-on experience leading EVT/DVT/PVT builds, manufacturing transfer, DFM optimization, supplier qualification, yield improvement, root cause analysis, and mass production ramp in partnership with contract manufacturers.
Strategic and hands-on leadership approach: Comfortable operating at both the system architecture level and in detailed technical reviews, balancing execution rigor with speed and business impact.
Strong cross-functional influence and communication skills: Demonstrated ability to align engineering efforts with Quality, Regulatory, Clinical, Logistics, and Product design, translating technical complexity into clear, actionable direction.

Nice To Haves

advanced degree (MS or PhD) preferred.
Prior startup or high-growth company experience preferred, with the ability to prioritize effectively, manage ambiguity, and deliver results in fast-paced settings.

Responsibilities

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.