Embedded Software Engineer

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.