Software Architect Job at Blackrock Neurotech (Plymouth)

Job Description

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.

Job Responsibility

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
Guide software design reviews
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

Requirements

Bachelor’s 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

Nice to have

Master’s 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

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Software Architect

Job Description

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