Director, Device Engineering (Medtech)

TL;DR

Director, Device Engineering (Medtech): Lead and scale multidisciplinary hardware and systems engineering team for at-home EEG medical devices with an accent on end-to-end product lifecycle management and regulatory compliance. Focus on architectural decisions, manufacturing scale-up, design controls, and ensuring safe, reliable products meeting FDA and ISO standards.

Location: Boston, MA (must be based in the Boston area for close partnership with the team)

Salary: $200,000–$215,000

Company

Leading at-home EEG platform revolutionizing precision medicine for brain disorders with FDA-cleared Waveband headband, AI algorithms, and large-scale Clinico-EEG database.

What you will do

• Own end-to-end lifecycle of home sleep testing products from concept through verification, regulatory submission, manufacturing transfer, commercialization, and sustaining engineering.
• Lead and expand high-performing device engineering team, mentoring engineers in hardware design, systems integration, and regulated development.
• Provide technical leadership on architecture, risk management, and trade-offs for new product introduction and mass production.
• Partner with QA, RA, Clinical Operations, and Logistics to maintain design controls, risk management, and audit readiness.
• Champion engineering excellence, best practices in system design, root cause analysis, and alignment with company strategy and OKRs.

Requirements

• Bachelor’s in Engineering (MS/PhD preferred)
• 10+ years post-graduate leading hardware/device teams delivering FDA/CE-regulated products
• 5+ years direct people management, hiring, performance management
• Deep expertise in wearable devices, embedded systems, architectural decisions, and cross-disciplinary problem-solving
• Fluency in FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 60601, design controls
• End-to-end lifecycle experience: EVT/DVT/PVT, manufacturing transfer, DFM, supplier qualification, yield improvement
• Strong cross-functional communication and strategic leadership in dynamic environments

Nice to have

• Startup or high-growth company experience

Culture & Benefits

• Equity, PTO, and comprehensive benefits package
• Cultural emphasis on curiosity, simplicity, composability, self-service, and empathy
• Diverse team focused on robust systems and high impact