Senior Firmware Engineer

A privately held medical technology company is developing a novel, non‑invasive therapeutic platform designed to provide patients with new treatment options for serious chronic conditions. The organization is building a multidisciplinary product development team to advance its technology through design verification, regulatory clearance, manufacturing transfer, and commercialization. This is a hands‑on startup environment where engineers have meaningful ownership, work closely across functions, and contribute throughout the full product lifecycle. Position Overview The company is seeking an experienced Firmware Engineer to lead the architecture, development, testing, and maintenance of embedded software for a regulated medical device platform. This individual will serve as a senior technical contributor and project lead, working closely with electrical, systems, software, quality, regulatory, clinical, and product development teams. The role includes both embedded firmware and supporting application software, with ownership spanning requirements definition, architecture, implementation, verification, documentation, release, and post‑development support. Key Responsibilitie Lead firmware and embedded software development for new medical device products and product enhancements Translate user, clinical, system, and product needs into clear software and firmware requirements Define software architecture, interfaces, algorithms, and functional specifications Develop, test, debug, and maintain embedded firmware that interfaces directly with electronic hardware Build device drivers, hardware abstraction layers, communications interfaces, and control software Develop signal processing and device‑control algorithms within hardware and performance constraints Support the development of associated application software and user interfaces Participate in system architecture decisions involving firmware, electronics, software, sensors, and mechanical components Generate design documentation supporting software development, design controls, and regulatory submissions Create software requirements, architecture documents, detailed designs, traceability records, test protocols, test reports, release documentation, and risk management files Lead and execute unit testing, integration testing, system testing, verification, and validation activities Develop test tools and support software and hardware tool validation Participate in laboratory testing, prototype builds, design iterations, and system troubleshooting Support device integration, compliance testing, system verification, and production release Establish and improve software development procedures, work instructions, coding standards, and development tools Ensure employees, consultants, and external development partners consistently follow established software processes Maintain source control, configuration management, versioning, and controlled software release processes Support cybersecurity planning, implementation, testing, and documentation for connected medical devices Collaborate with clinical and commercial stakeholders to translate workflow and usability needs into product requirements Provide technical support for field updates, product improvements, issue investigations, and feature enhancements Manage development activities within an Agile or iterative product development environment Communicate project status, technical risks, dependencies, and recommended solutions to cross‑functional leadership Support external engineering partners, vendors, and testing laboratories as needed Required Qualificatio Bachelor’s degree in computer science, software engineering, electrical engineering, computer engineering, or a related discipline At least four years of experience designing, developing, and verifying software or firmware for regulated medical device Demonstrated experience taking embedded software through formal medical device design control Strong embedded programming and debugging capabilities Experience developing firmware that interfaces directly with processors, sensors, electronics, or electromechanical systems Experience with software architecture, requirements development, detailed design, implementation, and verification Working knowledge of IEC 62304 and medical device software lifecycle requirements Familiarity with IEC 60601 and the development of electrically powered medical systems Understanding of FDA quality system and design control requirements Familiarity with European medical device regulatory expectations Experience creating software documentation within a controlled quality system Knowledge of software risk management, hazard analysis, and risk control implementation Experience with code reviews, static analysis, unit testing, integration testing, and system‑level verification Experience with source control, configuration management, and software release processes Ability to independently lead technical activities with limited oversight Strong analytical, organizational, written communication, and cross‑functional collaboration skills Preferred Qualificati Master’s degree in a relevant technical discipline Experience with VHDL, Verilog, or SystemVerilog Experience developing with FPGAs, systems‑on‑module, or similar embedded computing platforms Knowledge of algorithm and code optimization for memory, processing, power, timing, and hardware limitations Experience developing signal processing algorithms Experience with mobile application development Familiarity with user interface and user experience development Experience validating software development tools and automated test systems Knowledge of medical device cybersecurity guidance and implementation practices Experience supporting regulatory submissions or responding to regulatory questions Previous experience in a startup, early‑stage product development environment, or small technical teams #J-18808-Ljbffr Lumicity