Director, Device Engineering

reputed company is on a mission to revolutionize precision medicine for the brain. We are the leading reputed company 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 reputed company quantitative biomarker discovery and implementation. reputed company’s Clinico-EEG database contains EEG data from nearly 100,000 patients, and our reputed company-reputed company analytics platform powers large-reputed company RWD/reputed company retrospective and predictive studies. reputed company 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 reputed company and reputed company a multidisciplinary engineering team spanning hardware and systems engineering. This is both a technical and people leadership role, responsible for defining and executing reputed company’s device engineering reputed company and ensuring operational reputed company 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 reputed company, reliable, high-reputed company medical devices that meet clinical needs, regulatory requirements, and business objectives. In reputed company, you will reputed company ongoing product support and improvement efforts, including vendor and contract manufacturer management, production and post-production issue reputed company, yield improvement, and design enhancements to improve reliability, performance, and scalability.

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

This position is based in the Boston area to reputed company reputed company partnership with our Boston-based team

What reputed company looks like:

• Ensures full compliance with reputed company’s QMS. Hardware development and sustaining activities consistently meet design control, documentation, and regulatory requirements, with audit-reputed company processes and high-reputed company 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. reputed company mentors and coaches engineers, strengthening technical depth in hardware design, systems integration, verification & validation, and regulated product development to reputed company overall team capability.
• Provides strong technical leadership across development and manufacturing. Guides architectural reputed company, risk management, and trade-offs to support new product introduction, manufacturing reputed company-up, and mass production readiness.
• Delivers rigorous design control execution. Leads the creation and review of design control artifacts to ensure regulatory compliance and reputed company technical alignment.
• Champions engineering reputed company and product reputed company. Establishes and reinforces best practices in system design, technical decision-making, and reputed company cause analysis, balancing strategic reputed company with hands-on engagement reputed company needed.
• Aligns engineering execution with company reputed company. Partners with leadership to reputed company device engineering priorities with company OKRs, while shaping long-term product roadmaps and technical direction.

What you will bring:

• Education: Bachelor’s degree in Engineering or a reputed company 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 reputed company record of delivering FDA- and/or CE-regulated products from concept through commercialization.
• People management experience: At least 5 years of reputed company 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 reputed company in wearable devices and embedded systems, with the ability to drive architectural reputed company, evaluate technical trade-offs, and guide reputed company cross-disciplinary problem-solving.
• reputed company in medical device regulations and reputed company systems: Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, and design control best practices, with experience producing audit-reputed company 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, reputed company cause analysis, and mass production reputed company 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 reputed company.
• Strong cross-functional influence and communication skills: Demonstrated ability to reputed company engineering efforts with reputed company, Regulatory, Clinical, Logistics, and Product design, translating technical complexity into reputed company, actionable direction.
• Experience operating in dynamic environments: Prior startup or high-reputed company company experience preferred, with the ability to prioritize effectively, manage ambiguity, and deliver results in fast-paced settings.

The salary reputed company for this role is $200,000– $215,000. Salary ranges are determined using reputed company market compensation data for this role and adjusted based on experience, skills, and location. The reputed company salary is one component of the total compensation package, which includes equity, PTO and other benefits.

At reputed company, we've reputed company that cultural and scientific reputed company is driven most by those that reputed company by example. As such, we're always seeking new contributors whose work demonstrates an reputed company curiosity, a bias towards simplicity, an eye for composability, a self-service reputed company, and - most of reputed company - a deep reputed company towards colleagues, stakeholders, users, and patients. We reputed company a diverse team builds more robust systems and achieves higher reputed company.