Senior Director of Engineering

We are an early-stage medical device company in stealth, developing a non-invasive therapy that works with the brain's own physiology to address neurodegenerative disease and brain health. Experienced startup team with prior exits. More detail is shared with candidates under NDA.
The role
You will be our first engineering hire and the technical leader of the company. You will own the device from concept through design verification and pivotal clinical use, and you will build the engineering organization that gets it there. This is a hands-on role with broad scope. Early on you will be defining architecture and writing requirements yourself while managing outside design partners. Over time you will hire and lead the internal team.
What you'll do
Define the system architecture for the therapeutic device, including therapeutic delivery, patient interface, and physiological sensing
Translate clinical and physiological requirements into product requirements, specifications, and a practical development plan with realistic cost and timeline
Select, contract, and direct outside engineering and contract manufacturing partners, and decide what to build in-house versus outsource
Stand up design controls and a quality system suitable for an FDA submission (21 CFR 820 / ISO 13485, ISO 14971 risk management, IEC 60601, IEC 62304)
Partner with regulatory on the FDA pre-submission and De Novo strategy, including bench, safety, and usability testing plans
Support clinical investigators with devices, data capture, and engineering support for early feasibility and later pivotal studies
Contribute to IP strategy and work closely with inventors and patent counsel
Recruit and lead the engineering team as the company scales
What we're looking for
12+ years in medical device development, with at least 5 in engineering leadership
Direct experience taking a Class II (or higher) electromechanical device through FDA clearance or De Novo authorization
Deep familiarity with design controls, risk management, and the relevant IEC and ISO standards
Hands-on background in one or more of gas or fluid delivery systems, respiratory or anesthesia devices, capnography and patient monitoring, or embedded control systems
Track record of managing outside development firms and contract manufacturers on budget
Comfort operating at a zero-to-one stage
Clear communicator who can work fluently with physicians, neuroscientists, and investors
BS in mechanical, electrical, or biomedical engineering required

Work arrangement
Yes