Adraxe Corporation is an innovative medical device startup focused on the design, development, and launch of breakthrough, minimally invasive neuromodulation solutions to address unmet patient needs. The results from the first clinical epilepsy patients are encouraging and we are at the important stage of hiring key personnel, to accelerate our progress and starting our full product and clinical development. Our goal is to revolutionize neurological care with life-compatible, closed-loop neuromodulation therapies, starting with epilepsy.
Requirements
- Proven design experience designing software for complex Class II or Class III medical systems.
- Experience working within a regulated industry, operating within a medical quality system, and a solid understanding of IEC 62304, ISO 14971, ISO 13485, and FDA QSRs.
- Experience defining a security architecture.
- Experience with wireless protocols (e.g., BLE, proprietary RF, NFC) and interfacing with mobile/cloud platforms.
- Familiarity with safety classification of software items and software risk management.
- Experience with version control (e.g., Git), requirement management (e.g., DOORS, Jama), and issue tracking tools (e.g., Jira).
- Experience with secure boot, cryptography, and OTA firmware update strategies.
Responsibilities
- Define the SW design input requirements
- Lead the allocation of software functions across the system. This includes mobile application-based software, embedded software, and cloud services.
- Define and document the software architecture in compliance with IEC 62304 and FDA design control regulations.
- Define a security architecture and implement cybersecurity risk management aligned with FDA premarket cybersecurity guidance, AAMI TIR57, and AAMI TIR97
- Incorporate UX input into the architecture and design language.
- Define software test strategies across the platform.
- Develop software verification and validation strategies consistent with IEC 62304 lifecycle deliverables and ensure full traceability to system requirements.
Other
- Work cross-functionally to define the SW development process.
- Collaborate with systems engineering, electrical, mechanical, and quality teams to align hardware-software interface requirements and system-level design.
- Support identification of external partners and consultants together with internal stakeholders.
- Guide software design reviews.
- Understand patient and user risk and defining mitigation strategies.
