KardioGenics,Inc · 2 days ago

Principal Firmware Engineer

San Jose, CA

Full-time

Hybrid

Senior Level

10+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

Health CareSoftware

Hiring Manager

Mahesh Galgalikar

Insider Connection @KardioGenics,Inc

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Ownership of Firmware Development: Take over existing product and lead firmware development efforts, from requirements definition through design, coding, testing, debugging, and deployment.

FDA Compliance & Approval: Understand and implement firmware solutions that comply with FDA regulations for medical devices, and actively participate in the FDA approval process.

Quality Assurance: Develop and execute test plans to ensure high-grade clinical data generation.

Interdisciplinary Collaboration: Work closely with software, and data analytics teams to create an integrated, seamless system. Documentation: Create meticulous documentation for firmware designs and codes, compliant with industry and regulatory standards.

Production Scaling: Be responsible for the firmware aspect of scaling the device for mass production. Security: Implement best practices to ensure the device’s data integrity and security.

Customer Interaction: Work closely with clinicians and healthcare professionals to gather requirements and feedback for iterative development.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Firmware DevelopmentMedical Device RegulationsFDA StandardsISO 13485ISO 1497121 CFR Part 820Military StandardsMIL-STD-810GMIL-STD-461GMIL-STD-1275DMIL-STD-1472MIL-STD-882C/C++Embedded SystemsRTOSHardware InterfacingProblem-SolvingInterpersonal CommunicationLeadershipTiny MLOn Chip Deployment

Required

Bachelor’s or Master’s degree in Electrical Engineering, Computer Science, or a related field.

Minimum of 10 years of experience in firmware development, with at least 3 years in a medical device environment.

Familiarity with FDA regulatory standards relevant to medical device firmware, such as ISO 13485, ISO 14971, and 21 CFR Part 820.

Understanding of military standards like MIL-STD-810G for environmental testing, MIL-STD-461G for electromagnetic interference testing, MIL-STD-1275D for power requirements, MIL-STD-1472 for human engineering design criteria, including usability and ergonomics for military systems, safety and reliability, MIL-STD-882 for system safety program requirements and engineering processes to minimize risks in military systems.

Proficient in C/C++, embedded systems, real-time operating systems (RTOS), and hardware interfacing.

Strong verbal and written communication skills for interdisciplinary collaboration and documentation.

Proven track record of successfully leading engineering teams through product development and launch.