Senior Embedded Software Engineer – Medical Devices

Theuniversityunion; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Location Enhanced Compliance Inc. in Los Angeles, CA is seeking an experienced software/firmware engineer to lead regulatory-compliant development for active implantable medical devices.

You will work across hardware, software, and regulatory teams to deliver safe, high-quality medical device software. The role requires 5–7 years of software development, strong C/C++, Python skills, and experience with IEC 62304, ISO 13485, and FDA 21 CFR Part 820.

Qualifications

• Bachelor's or master's degree in computer science, software engineering, or related field.
• 5–7 years of software development experience.
• Proven experience managing medical device software development teams.
• Strong programming skills in C#, C++, Java, Python and software architecture principles.
• Solid understanding of embedded systems, RTOS, and hardware/software integration.
• In-depth experience with ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304, cybersecurity.

Responsibilities

• Participate in technology evaluations, technical specification development, and validation of software/firmware architectures.
• Support software/firmware specification development and integration for active implantable medical devices.
• Ensure development aligns with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards.
• Collaborate with hardware, systems, risk management, regulatory, and clinical teams for device integration.
• Maintain design documentation, traceability matrices, and SDLC artifacts for regulatory submissions.
• participate in software/system risk management activities throughout the SDLC.
• Participate in testing strategies and design verification protocols for software/firmware.
• Provide inputs on low-power embedded systems and wireless communication (BLE, NFC, RF).
• Establish SDLC processes aligning with internal QMS and conduct testing/debugging using relevant tools.
• Support regulatory submissions (510(k), PMA, CE Mark) related to software/firmware changes.
• Develop test scripts and automation frameworks; experience with Selenium.

Skills

Python

C/C++

Selenium

Claude

Education

Bachelor's or Master's in Computer Science

Job description

Location Enhanced Compliance Inc. in Los Angeles, CA is seeking an experienced software/firmware engineer to lead regulatory-compliant development for active implantable medical devices.

You will work across hardware, software, and regulatory teams to deliver safe, high-quality medical device software. The role requires 5–7 years of software development, strong C/C++, Python skills, and experience with IEC 62304, ISO 13485, and FDA 21 CFR Part 820.