> Markdown version of [/jobs/ext/4411429-principal-software-engineer-medical-devices](https://www.wearedevelopers.com/jobs/ext/4411429-principal-software-engineer-medical-devices). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Principal Software Engineer - Medical Devices - **Company:** Gilero, LLC - **Location:** Durham, NC, United States - **Contract:** Permanent contract - **Skills:** Agile Methodology, Software Applications, JIRA, Unit Testing, Bug Tracking Systems, C++ (Programming Language), Code Review, Computer Programming, Continuous Integration, Linux, Microprocessors, Middleware, Embedded Software, Firmware, Network Protocols, Software Tools, Reduced Instruction Set Computing, Software Configuration Management, Software Engineering, Systems Integration, Test Data, Jama (Software), PIC Microcontroller, Gitlab, Integration Tests, Data Management, Software Coding, Docker, Hardware Debugging - **Published:** October 10, 2026 - **Apply:** https://www.healthjobsnationwide.com/node/15600597/apply-external ## About the Role * BS in Engineering or equivalent technical degree. * 12+ years relevant experience. * Experience developing embedded software for medical devices, preferred. * Proven ability to lead a product development program from concept to market release. * Proven track record of fully developing embedded software and architectures. * Expertise in software development in C/C++ for microcontrollers / microprocessors * Expertise and experience integrating firmware and application software systems, preferred. * Expertise in using various software tools including Gitlab, Tessy, Docker, JIRA, JAMA, preferred. * Expertise with programming RISC and ARM-based microcontrollers, preferred. * Proficiency with hardware debugging (digital and analog), preferred. * Expertise in OS coding techniques, IP protocols, interfaces and data management, preferred. * Proficiency with development drivers and middleware for Linux, preferred. * Proficiency with software configuration management tools, defect tracking tools, and peer review, preferred. * Working knowledge of agile methodologies and continuous integration/continuous * deployment (CI/CD) practices, preferred. * Working knowledge of cybersecurity principles and considerations in medical device software development, preferred. * Proficiency with developing products for compliance with FDA 21 CFR Part 820.30, 21 CFR * Part 4, ISO14971, ISO 13485 and EU MDR, preferred., * Demonstrates and consistently supports Sanner America's Core Values of Collaboration, Innovation, Excellence, and Integrity. * Productive in a fast-paced, entrepreneurial environment. * Commits to excellence and quality service to external and internal customers. * Adheres to established policies and procedures, while contributing to continuous improvements. Eligibility To Work: * Ability to pass a pre-employment background check. * Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future. * Sanner America does not offer sponsorship for employment authorizations (work visas). * We are an E-Verify employer and confirm work authorization for all new hires. ## Description * Acts as technical lead and thought leader throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices. * Designs, develops, and tests embedded firmware. * Serves as an architect and/or software technical lead for product development projects. * Leads and participates in systems and integration testing, unit testing, and code reviews. * Analyzes and enhances efficiency, stability and scalability of system resources. * Coordinates activities with other software developers both internal and external. * Leads and participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning. * Authors and advises on test planning and protocols for design verification and validation. * Analyzes test data, interprets results, and formulates conclusions. * Maintains the Design History File (DHF) to ensure documents are complete, accurate, current, and compliant with regulations. * Owns and manages the development and improvement of software engineering tools, processes, and systems and trains others that are working within and managing those systems. * Identifies technical opportunities and generates work for themselves and across the company. * Defines and leads objectives and oversees quality of output for large or complex projects. * Solves open-ended problems and tasks with a high level of decision making and autonomy. * Formulates and develops detailed project deliverables with minimal management oversight. * Communicates technical risks and proposed solutions clearly and directly with the customer. * Sources and interfaces with third party vendors. * Acts as subject matter expert (SME) lead in one or more areas and remains current and contributes to industry trends. * Participates in seminars or other speaking engagements on behalf of the company. * Supports business development efforts as a SME to potential customers and leading multidisciplinary engineering estimations. * Refers new business to the company based on established trust and rapport in industry. * Acts as a role model and mentor; coordinates and delivers group training sessions. * Participates in recruitment activities including interview panels. * Travel will be required, as necessary (typically less than 10%).