Direct message the job poster from KardioGenics,Inc
Mahesh Galgalikar
CEO KardioGenics,Inc | “ Einstein Visa “ Recipient | Global Panelist at MIT Technology Review
About Kardiogenics, Inc.
Kardiogenics is a pioneering healthcare technology company specializing in a transformative single-device platform that aggregates clinical data. This innovative technology aims to revolutionize healthcare analytics, machine learning, and AI-based models, both retrospectively and predictively. We are also working on a virtual clinic for specialty care offerings.
Position Overview:
Kardiogenics is looking for an experienced Principal Firmware Engineer who will take ownership of our state-of-the-art device platform. The candidate will be responsible for the entire firmware lifecycle, from production to on field deployment, including taking the product through FDA approvals.
Key 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.
Qualifications:
Educational Background: Bachelor’s or Master’s degree in Electrical Engineering, Computer Science, or a related field.Experience: Minimum of 10 years of experience in firmware development, with at least 3 years in a medical device environment.FDA Regulations: 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,Programming Skills: Proficient in C/C++, embedded systems, real-time operating systems (RTOS), and hardware interfacing.Communication Skills: Strong verbal and written communication skills for interdisciplinary collaboration and documentation.Leadership: Proven track record of successfully leading engineering teams through product development and launch
Nice to Haves:
Machine Learning & AI: Exposure to On chip deployment of tiny ML models and analytics would be a strong advantage
Employment type
Full-time
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