Senior Software Engineer - Medical Device #1527

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.,Los Angeles, CA, 90001,United States
• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree

Description

About ECI

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

What You'll Do

• Participate in technology evaluations, technical specification development, technical assessments and validation of software/firmware architectures, embedded software, and system integration aspects of active implantable medical devices.
• Support the software/firmware specification development, software/firmware architecture, embedded software/firmware development, and integration for active implantable medical devices.
• Ensure that software/firmware development aligns with IEC 62304, FDA, ISO 13485, ISO 14971 and other regulatory standards governing medical device software/firmware.
• Collaborate with cross-functional teams, including hardware engineers, systems engineers, risk management, regulatory affairs, and clinical teams, to ensure seamless device integration.
• Maintain thorough design documentation, traceability matrices, and software development lifecycle (SDLC) artifacts for regulatory submissions.
• Participate in software and system risk management activities throughout the SDLC.
• Participate in testing strategies (Unit/Integration) and design verification protocols to verify software/firmware functionality.
• Provide technical inputs on low-power embedded systems and wireless communication (e.g., BLE, NFC, RF telemetry)
• Establish and document software/firmware development lifecycle (SDLC) artifacts and processes to align with internal quality management systems (QMS).
• Perform 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 regulatory teams on 510(k), PMA, or CE Mark submissions involving software/firmware-related changes.
• Experience with developing test scripts and test automation framework.
• Experience with automation tools such as Selenium
• Experience working with Claude for code and script development - nice to have only
• Experience with Python and C/C++

What We Look For

• Bachelor's or master's degree in computer science, Software Engineering, or a related technical field.
• Minimum of 5-7 years of experience in software development
• Proven experience managing medical device software development teams
• Strong technical background with expertise in one or more programming languages (e.g., C#, C++, Java, Python) and software architecture principles.
• Solid understanding of embedded systems, real-time operating systems, and hardware/software integration.
• In depth working experience with medical device software development lifecycle processes and regulatory compliance (e.g., ISO 13485, FDA 21 CFR Part 820, ISO 14971, IEC 62304, Cybersecurity).
• Demonstrated ability to function as a productive team member in a high performing environment.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.