About Us
iota Biosciences, a wholly owned subsidiary of Astellas Pharma US, is advancing a new class of bioelectronic medicines through the development of fully implantable Class III medical devices. Our proprietary technologies open therapeutic and diagnostic possibilities not previously accessible to clinicians.
Together with Astellas, we are committed to patient-centric design, scientific and engineering excellence, and cross-functional teamwork. These principles guide us in bringing transformative, first-of-its-kind technologies into the clinic and closer to patients.
The Role
Design, build, and own the core software architecture for a brain–computer interface (BCI) medical device that restores volitional movement for people living with paralysis.
As a Staff Software Engineer, you will define and implement end-to-end software systems spanning embedded embedded software, backend services, and machine-learning (ML) deployment pipelines, while operating within IEC 62304 and FDA regulatory requirements. You will be the technical anchor for a growing software organization, setting foundational architectural direction in a greenfield environment while balancing patient safety, system reliability, performance, and regulatory compliance.
Your work will directly shape the therapeutic effectiveness, scalability, and long-term evolution of a first-generation BCI medical device. This role is an opportunity to help redefine what is possible for people living with paralysis.
Key Responsibilities
Design and implement embedded device software supporting real-time data streaming, on-device ML inference, USB communication with exoskeleton, and safety-critical logging.
Architect backend services and RESTful APIs serving clinician portals, patient applications, and R&D tools; build data pipelines for time-series neural data with HIPAA/FDA compliance and audit trail logging.
Establish software development processes aligned with IEC 62304, including version control, code review, testing, and documentation standards.
Partner with clinical teams on design control activities: document software requirements specifications, design specifications, verification/validation plans, and traceability matrices for FDA submission.
Recruit and oversee contractors for infrastructure-as-code, DevOps, and embedded systems as needed; define scope and ensure deliverables integrate cleanly into codebase.
Required Qualifications
Embedded systems: Strong experience with embedded Linux or RTOS; comfortable with low-level debugging, real-time constraints, and safety-critical design patterns.
Backend architecture: You have designed production backend systems (Python, C++ or similar); you have experience with RESTful APIs, real-time streaming, and cloud service integration.
System-level thinking: Ability to design coherent architecture across embedded, cloud, and web domains, balancing regulatory, performance, and cost constraints.
AWS or equivalent cloud: Demonstrated production experience on AWS (or equivalent), including related services (storage, compute, ML pipelines, IAM, networking).
Medical device software: Experience developing software for FDA-regulated medical devices.
Technical leadership: Track record of establishing engineering practices, mentoring engineers, and taking ownership in ambiguous situations.
Preferred Qualifications
Experience developing Class III medical device software.
HIPAA compliance or clinical trial software background.
Familiarity with BioT platform or similar medical-grade cloud solutions.
Real-time ML inference on edge devices.
Medical device documentation, traceability tools, or FDA submission experience.
What sets this role apart
This role offers an opportunity to drive technical direction across a growing software organization, owning foundational architecture and design decisions for a novel BCI medical device. With no simple or safe blueprint to follow, success will depend on navigating ambiguity, building cross-functional consensus, and making high-stakes technical decisions that will directly impact patient outcomes.
Top Skills
What We Do
iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company working to develop pioneering bioelectronics to advance the treatment and management of disease. Founded in 2017 to build on the award-winning ultrasound technology invented at the University of California, Berkeley, iota Biosciences is committed to improving human life and bringing our groundbreaking approaches to the patients who need them. Using innovative science and technology, our mission is to create and develop state-of-the-art diagnostic and therapeutic bioelectronic devices that are safe and effective. We are working to transform the way doctors manage and treat disease to make a life-changing difference for patients. We are proud and privileged to be powered by Astellas, a leading global pharmaceutical company that brings experience, reach and rigor. With a shared transformational vision and a commitment to the realization of greater value to patients, together we are creating innovative technologies that will change patients’ lives.
