Job Description
READ FIRST! HARD REQUIREMENTS/NON-NEGOTIABLES:
- MUST have 8+ years of software development experience in the medical device industry (Master’s degree may substitute for one (1) year of experience.)
- MUST have 5+ years of embedded or application software development for medical devices
- No H1B Visa Sponsorship
- Must be able local to the Irvine, CA area, no relocation support
- Must have a BS in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or equivalent
- MUST have strong C/C++ skills for firmware development
IF YOU MEET ALL SIX (6) REQUIREMENTS ABOVE, PLEASE CONTINUE BELOW:
About the Role:
Our Client is seeking a seasoned Principal Software Engineer to lead the development of our software products—from mobile apps and web frontends to backend systems. In this role, you’ll guide software architecture, drive integration efforts, and ensure our development processes meet medical device regulatory standards. The ideal candidate possesses extensive experience in application and embedded software development, as well as expertise in Android and iOS platforms, test frameworks, and regulatory-compliant practices for medical devices.
Essential Duties and Responsibilities:
- Primary contributor in defining the Client’s software architecture and leading software development across all software platforms.
- Collaborate with Quality Engineers to develop and implement robust and efficient testing strategies, supporting risk management efforts for all software applications.
- Evaluate compliance and ensure that software and firmware development align with IEC 62304, FDA, ISO 13485, ISO 14971, and other regulatory standards governing medical devices.
- Oversee the development of testing strategies (Unit/Integration) and Design Verification protocols to verify software/firmware functionality post-acquisition.
- Support software/ firmware testing, debugging, and verification efforts using tools such as unit testing frameworks, hardware-in-the-loop (HIL) simulations, and automated test environments.
- 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 and processes to align with internal quality management systems (QMS). Maintain thorough design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
- Establish best practices for software/firmware development, including coding guidelines, code reviews, and adherence to internal QMS.
- Foster a culture of innovation, continuous improvement, and knowledge sharing within the R&D team.
Education and/or Work Experience Requirements:
- B.S or higher in Computer Science, Electrical Engineering, Computer Engineering, Software Engineering, or related major.
- 8+ years of experience in software development. (Master’s degree may substitute for one year of experience.)
- 5+ years in embedded or application software development for medical devices.
- Sound knowledge of software engineering principles and practices, such as object-oriented and API principles.
- Experience in developing mobile applications in an FDA-regulated environment or other regulated industry.
- Strong C/C++ skills for firmware development.
- Hands-on experience and knowledge in software applications utilizing BLE stacks and BLE API on mobile platforms.
Additional Requirements:
- Excellent verbal and written communication skills – including the ability to contribute technically to and work within cross-functional team environments.
- High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently.
- Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can do” attitude and ability to work well under pressure.
- Strong organizational and multitasking skills, with a high level of attention to detail and a proactive approach to problem-solving.
- Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint); familiarity with Microsoft Teams is a plus.
- Prior startup experience preferred but not required.
Bonus Points:
- Prior startup or early-stage company experience.
- Familiarity with Microsoft Teams.
Physical Requirements:
- Must be able to lift up to 20 lbs.
- Must be able to work extended amounts of time standing or sitting based on projects and priorities.
Job Tags
Work experience placement, Local area, Relocation package, H1b,