Job Description

Job Title: Software Embedded Engineer

Duration: 12+ Months (Possible extension)

Location: Irvine, CA 92618

Hybrid Role, 3days onsite

Responsibilities:

• In this role, you will be part of evaluation, integration of software and firmware technologies for medical devices for Urology products.
• Experience with application software development, embedded systems, android platform, test frameworks, and regulatory compliant medical device software development processes.
• Participate in technology evaluations, technical assessments and validation of software architectures, embedded software, and system integration aspects of acquired implantable medical devices.
• Support software architecture, development, testing strategies and risk management activities for software applications
• Evaluate compliance and ensure software/firmware development aligns with IEC 62304,
• FDA, ISO 13485, ISO 14971and other regulatory standards governing medical devices.
• Contribute to defining test strategies (Unit/Integration) and draft design verification
• protocols to verify software/firmware functionality post-acquisition.
• Support software/ firmware testing, debugging, and verification e􀆯orts using tools such as
• unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
• Identify potential risks, cybersecurity vulnerabilities, and integration challenges in acquired technologies.
• Ensure acquired software meets medical device cybersecurity and safety standards, including FDA premarket cybersecurity guidance, IEC 62443.
• Collaborate with cross-functional teams, including hardware engineers, systems engineers, quality, regulatory affairs, manufacturing and PMO to ensure seamless device integration.
• Establish and document software development lifecycle (SDLC) artifacts to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
• Provide technical inputs on low-power embedded systems, wireless communication (e.g. BLE, NFC, RF telemetry), and real-time operating systems (RTOS).

Education/Experience:

• B.S or M.S in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering or related major.
• 3+ years of experience in software development, with 1+ years in embedded or application software for medical devices.
• Sound knowledge of software engineering principles and practices.
• Knowledge of programming languages such as Swift, Java, Dart, or Objective-C and mobile operating systems and platforms such as iOS and Android.
• Experience in developing mobile applications in an FDA regulated environment or other regulated industry.
• Strong C/C++ skills for programming microcontroller systems.
• Knowledge and use of OOP design principles, API design principles.
• Knowledge in low-power embedded systems, real-time operating systems (RTOS), and microcontroller-based firmware development.

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