Staff Firmware Engineer

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. What You’ll Do As our Staff Firmware Engineer, you'll serve as a principal technical authority — shaping the firmware architecture, driving strategic initiatives, and mentoring the broader engineering team — while remaining deeply hands-on in the development of next-generation Class III active implantable devices: - Set technical direction – Define and own the long-range firmware architecture, partnering with technical leadership to drive the roadmap and set engineering standards across embedded subsystems. - Deliver safety-critical firmware – Lead design, implementation, and verification of firmware for power management, ASIC interfaces, BLE communication stacks, and security subsystems, with an uncompromising focus on safety and correctness. - Own BLE security – Drive BLE security architecture from the ground up — including secure pairing/bonding, AES-CCM encryption, MITM protection, secure key storage, and firmware signing — establishing iota's security posture for connected implantable devices. - Enable innovation and quality – Integrate and debug complex subsystems, lead root-cause investigations, and support reliability, verification, and compliance activities aligned with IEC 62304 and related medical device standards. - Elevate the team – Serve as a technical mentor and collaborator across mechanical, electrical, systems, and quality teams, as well as external partners, from concept through clinical readiness. Responsibilities: - Architect and lead the development of embedded software for iota's devices across the full product lifecycle, defining patterns and standards for the firmware team. - Own the BLE security posture for iota's connected implantable devices: design and implement secure pairing/bonding, AES-CCM encryption, MITM protection, secure key storage, and firmware signing; establish threat models and drive security reviews. - Optimize RF/BLE power delivery and control systems on embedded platforms; apply modern software techniques to support multiple products while maximizing reuse. - Collaborate with software engineers to design the data infrastructure for efficiently routing all required data from embedded processors to application software, cloud backend, and configuration services. - Lead and own the process of verifying embedded software to medical regulatory standards, maintaining an industry-leading development pace. - Elevate team software development processes and infrastructure, including DevOps activities, code review standards, and onboarding of junior engineers. What you’ll bring: - B.S. in Computer Science, Electrical Engineering, or related field with 10+ years of industry experience programming in C/C++ - OR M.S. in Computer Science, Electrical Engineering, or related field with 8+ years of industry experience programming in C/C++ - Demonstrated BLE security experience — pairing/bonding procedures, AES-CCM encryption, MITM protection, secure key storage, and firmware signing - Deep expertise in Real-Time OS (RTOS) for embedded platforms - Extensive experience with Bluetooth Low Energy (BLE) protocol stacks and wireless communication subsystems - Proven track record of leading firmware architecture decisions and mentoring engineers across a team Preferred qualifications: - Experience with test automation tools (e.g., Jenkins) and modern software test/deployment methodologies - Comfortable working in a Python environment for tests and prototyping - Substantial experience with ISO 13485 (QMS), ISO 14971 (risk management), and/or IEC 62304 (medical device software) - Experience authoring technical design documentation, threat models, and security risk assessments - Prior experience in Class II/III medical device development or other highly regulated embedded domains - Why Join Us - Mission with impact – see your work directly enable life-changing therapies for patients who need them most - Cutting-edge platform – work on proprietary technology that is redefining what's possible in bioelectronic medicine - Staff-level influence – shape not only the product but the company's long-term technology roadmap and engineering culture iota offers a very competitive benefits package that includes the following: Health & Wellness Comprehensive health coverage for you and your family, covered at 100% Access to quality dental and vision coverage Onsite Gym in Alameda Work-Life Balance Generous vacation pay Paid parental leave Options for flexible work schedules Competitive Compensation Annual Bonus Plan Long Term Incentive Plan (LTIP) 401(k) plan with employer match