inogen
Principal Architect, Embedded Platforms & IoMT
Requirements
Deep expertise in architecting embedded systems and software engineering, especially for real-time systems.
Solid understanding of cybersecurity best practice for medical devices.
Experience with business analysis techniques and processes.
Professional background in both computer hardware and software analysis.
Extensive knowledge of FDA regulations and compliance for medical devices.
Min 5 years in software development and architecture within the Medical Device industry or another regulated industry.
Responsibilities
Own the firmware/software architecture for medical devices, including product security architecture and security solutioning, and ensure traceability from requirements through implementation, verification, and system integration.
Define and evolve a forward-looking technical roadmap aligned to business strategy, clinical/regulatory needs, and product lifecycle considerations.
Produce clear architectural designs and detailed specifications; evaluate tradeoffs (performance, safety, security, cost, schedule) and guide practical implementation.
Lead design reviews and technical decision-making; establish and enforce architecture guidelines, coding standards, and best practices.
Remain hands-on by designing and implementing the most critical components, performing code reviews, and supporting verification, test automation, and debug activities.
Serve as the escalation point for complex technical issues; drive structured troubleshooting, root-cause analysis, and corrective/preventive actions.