Preclinical & Clinical Engineering Lead

Subsense•Mountain View, CA

9d•Hybrid

About The Position

Subsense is a deep-tech company developing the worldâ€™s first non-surgical, bidirectional brain-computer interface powered by plasmonic and magnetoelectric nanoparticles. Our mission is to unlock direct communication between the human brain and AI - starting with medical applications such as stroke recovery and moving toward cognitive enhancement for healthy users. Headquartered in Palo Alto, Subsense brings together leading scientists and engineers to redefine the future of humanâ€“machine interaction. We are hiring an experienced, hands-on engineer to own the engineering side of our translational program, from large-animal studies through first-in-human (FIH) and early feasibility studies (EFS). You will be in the operating room or vivarium on study days. You will set up, run, and troubleshoot our hardware/system alongside clinicians, veterinarians, system engineers and scientists, and you will make sure every study produces data we can trust and use. You will design and run the work mainly within system engineering, and you will bring a working network of large-animal labs, preclinical CROs, academic collaborators, and clinical investigators that you can activate quickly. You will work closely with our R&D, and with cross functional teams, and you will be the person who turns what we learn in each study into the next engineering iteration.

Requirements

BS/MS/PhD in biomedical, electrical, mechanical, or systems engineering, or a related field.
5+ years in medical device development, including hands-on engineering support of in vivo large-animal studies (swine, sheep, or non-human primate). You have been in the OR or vivarium running equipment, not only reviewing reports.
Has taken at least one Class III medical device (ideally neurological, neurovascular, or implantable/active) from preclinical studies into a first-in-human, EFS, or pivotal clinical study.
Established working relationships with preclinical CROs and/or academic large-animal facilities, including experience scoping, contracting, and managing outsourced GLP and non-GLP studies.
Working knowledge of GLP (21 CFR Part 58), IACUC/animal welfare requirements, design controls (FDA QMSR / ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993), and Good Clinical Practice for device trials (ISO 14155).
Strong hands-on troubleshooting of device-animal interfaces and integrated systems under time pressure, and judgment about how a technical issue affects animal welfare, patient safety, study validity, and data interpretation.
Experience writing test protocols and reports, analyzing experimental data, and documenting clear, evidence-based conclusions in a controlled-document environment.
Comfortable working in surgical and vivarium environments (sterile technique, PPE, long procedure days, radiation-safety practices around fluoroscopy), and able to travel.
Clear communicator who works well with clinicians, veterinarians, engineers, scientists, and regulators, and who knows when to solve a problem independently and when to escalate it.

Nice To Haves

Experience with neuromodulation, neural recording/BCI, deep brain stimulation, or neurovascular/endovascular devices, especially studies targeting deep-brain structures.
Experience with magnetic/optical/photonic/ultrasound systems for in vivo applications.
Experience with wearable or head-mounted external systems: positioning, coupling, exposure control, thermal monitoring, and acoustic/magnetic/optical output characterization.
Stereotactic or image-guided neurosurgical procedures and image registration.
Contributed to FDA Pre-Submissions, IDE applications, or Breakthrough Device Designation requests.
Experience at international CROs or sites (e.g., EU) and with study data standards and transfer.
IEC 60601 electrical safety/EMC and human factors/usability engineering (IEC 62366).
Data and analysis tools: Python and MATLAB for analysis; neural data acquisition and analysis; statistics and clinical data capture.

Responsibilities

Plan, prepare, and personally support non-GLP and GLP large-animal studies.
Work with study directors, veterinarians, engineers and scientists on study design, device configuration and operating parameters, device-related endpoints, data capture plans, and deviation handling. Owning IACUC protocol preparation and amendments.
Install, calibrate, and operate study systems in the operation suite or vivarium, including stereotactic or image-guided positioning, delivery hardware, and integration with anesthesia monitoring and imaging (fluoroscopy/X-ray, CT, MRI, ultrasound). Resolve problems in real time.
Write SOPs, setup checklists, and pre-study device readiness checks (configuration control, calibration, functional verification) so that results can be compared across animals, cohorts, and sites.
Identify, qualify, and manage preclinical CROs and academic large-animal labs in the US and internationally. Scope studies, review quotes and statements of work, build timelines, transfer methods, run site visits, and keep technical oversight of outsourced work.
Produce the device-side preclinical evidence (performance, safety, biocompatibility (ISO 10993) inputs, electrical/thermal/acoustic/magnetic exposure, usability) needed for Pre-Submissions and an IDE/EFS application, working with Regulatory and Quality.
Translate the animal procedure into a clinical workflow. Support site selection and setup, develop device training for neurosurgeons, interventional neuroradiologists, and clinical staff, and act as the technical lead in the room during early human cases.
Define device logging, data capture, and chain-of-custody requirements so the team can reconstruct operating conditions, investigate anomalies, and defend data quality.
Lead root-cause investigations of device deficiencies, deviations, and adverse events. Turn study observations and user feedback into prioritized design inputs, engineering updates, and verification changes.
As a hands-on technical leadership role, guide and train the engineers, technicians, and contractors who support study execution.