iota Biosciences, Inc. powered by Astellas · 1 day ago
Staff Software Engineer
Alameda, CA
Full-time
Hybrid
Lead/Staff
$180K/yr - $220K/yriota Biosciences, a subsidiary of Astellas Pharma US, is advancing bioelectronic medicines through the development of implantable medical devices. The Staff Software Engineer will design and implement software systems for a brain-computer interface medical device, ensuring compliance with regulatory standards while shaping its therapeutic effectiveness.
BiotechnologyLife ScienceMedical
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
Qualification
Required
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
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
Company
iota Biosciences, Inc. powered by Astellas
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
51-200 employees
H1B Sponsorship
iota Biosciences, Inc. powered by Astellas has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (15)
2023 (6)
2022 (11)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$15MKey Investors
Astellas Pharma,Bold Capital Partners,Horizons Ventures
2020-10-15Acquired
2018-12-27Series A· $15M
Leadership Team
Michel Maharbiz
Chief Executive Officer
Recent News
Google Patent
2025-05-05
Google Patent
2025-05-05
2025-05-05
Company data provided by crunchbase