Others, Connecticut
Job Summary
Lead firmware architecture, design, development, and validation for complex medical device systems, ensuring compliance with regulatory standards (IEC 62304, FDA, MDR). Drive hardware–software integration, verification testing, and design control processes while providing technical leadership, cross-functional coordination, and timely delivery of high-quality, safe, and effective products.
Key Responsibilities
Define and deliver firmware architecture for medical device systemsDevelop, debug, and integrate embedded firmware and hardwareEnsure compliance with IEC 62304, FDA, and design control guidelinesCreate and execute verification & validation (V&V) test protocols and reportsDrive design inputs, risk analysis, and technical strategyLead cross-functional collaboration and NPI executionMentor engineers and enforce best practices in firmware developmentManage stakeholders and ensure timely project delivery
Skill Requirements
Strong embedded firmware development in C/C++ Experience with microcontrollers (ARM Cortex-M) and peripherals (SPI, I2C, UART, CAN)Knowledge of RTOS (FreeRTOS/Embedded Linux) and bare-metal systemsExpertise in hardware–software integration and debugging Understanding of analog/digital circuits and signal processing Experience with medical device standards (IEC 62304, FDA, MDR, ISO) Hands-on in Verification & Validation (V&V) and test protocol creationFamiliarity with design control, risk management, and quality processes Exposure to tools like Altium, lab instruments (oscilloscope, etc.) Strong analytical, problem-solving, and communication skills
Other Requirements
7+ years in embedded/firmware developmentMedical device & regulatory experienceStrong debugging & prototyping skillsExperience in NPI & cross-functional teamsGood communication and leadership skillsWillingness for occasional travel
Maximum Salary (US): 176000
Minimum Salary (US): 115000
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