Job Description

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.

About the role

This role will architect the software of the Adraxe Seizure Alleviation Platform. The role will be responsible for the full SW architecture including capturing design inputs, allocating SW functions across system components, creating the security architecture, defining cloud storage strategy, defining the SW test strategy, incorporating UI/UX inputs into design, and defining partnerships for input and implementation. This position will also help define SW engineering processes, contribute to overall system architecture definition, and ensure regulatory needs are met across the system.

Software is a critical component in the Adraxe closed-loop therapy for epilepsy and this position will significantly enable the success of the platform and Adraxe as a company.

This position will report directly to the VP and Chief engineer and will have significant input into Adraxe strategy, planning, and operations.

What youll do

• Work cross-functionally to define the SW development process.
• 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.
• Collaborate with systems engineering, electrical, mechanical, and quality teams to align hardware-software interface requirements and system-level design.
• 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
• Support identification of external partners and consultants together with internal stakeholders.
• Incorporate UX input into the architecture and design language.
• Understand patient and user risk and defining mitigation strategies.
• 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.
• Lead software Risk analysis and contribute to system risk analyses to ensure compliance with ISO 14971.
• Mentor software engineers and ensuring adherence to architectural principles and coding standards.
• Drive interaction with Data Science and Software international extended team members.

Qualifications

• Bachelors Degree in Computer Science or similar.
• Minimum of 10 years working as a Software Engineer with 3+ years in a software architect or principal engineer role.
• 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).
• Strong written and verbal communication skills.
• Experience selecting and managing vendors.
• Ability to operate across the lifecycle of a design.
• Willingness to work on a small team in a fast-paced environment.

Preferred Qualifications

• Masters or Ph.D. in Computer Science or similar.
• Experience with Class III active implantable medical systems.
• Understanding of medical device software standards and regulations and experience creating software development procedures and work instructions.
• A history of successful medical device software architectures.
• Experience with secure boot, cryptography, and OTA firmware update strategies.
• Knowledge of software development management techniques.
• Experience working with teams spread across multiple geographies.
• An understanding of cloud storage and cloud compute architectures.
• Familiarity with DevOps practices, CI/CD pipelines, and test automation in regulated environments.
• A track record of Intellectual Property generation.
• 15+ years working as a software engineer.

Physical and Other Requirements

• This position is located in Plymouth MN.
• This position is a hybrid position with an expectation of roughly 75% in office and 25% remote work.
• This position requires approximately 25% Travel including international travel.

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