Bachelor's or master's degree in computer science, Software Engineering, or a related technical field
5-7 years of experience in software development
Expertise in programming languages such as C#, C++, Java, or Python
Solid understanding of embedded systems and real-time operating systems
Experience with medical device software development lifecycle and regulatory compliance standards
Ability to work effectively in a high-performing team environment
Responsibilities
Participate in technology evaluations and technical specification development for medical devices
Support software/firmware specification and architecture development
Ensure compliance with IEC 62304, FDA, ISO 13485, and ISO 14971 standards
Collaborate with cross-functional teams for seamless device integration
Maintain design documentation and SDLC artifacts for regulatory submissions
Engage in software and system risk management activities
Develop and execute testing strategies for software/firmware functionality
Benefits
Collaborative work environment with cross-functional teams
Opportunity to work on cutting-edge medical technology
Involvement in regulatory submissions and compliance processes
Professional development opportunities in a high-performing team
Exposure to low-power embedded systems and wireless communication technologies
Full Job Description
Description
Please No Agencies.
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
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
