Embedded Software Engineer

• Develop and maintain embedded software for 32-bit microcontrollers using C and C++, ensuring compliance with medical device standards.
• Collaborate with stakeholders to define software requirements, assess product risks, and devise mitigation strategies, focusing on logical decision-making and pragmatic solutions.
• Select and evaluate system hardware and software architectures to meet clinical, operational, and quality requirements, conducting thorough trade-off analyses.
• Participate in the entire software development lifecycle for medical devices, adhering to IEC62304 standards, including planning, implementation, testing, and documentation.
• Conduct unit and system-level testing in collaboration with the test team, supporting software verification and validation (V&V) activities.
• Define software architecture, engage in risk assessment and failure mode analysis, develop code, and review test plans and V&V results when assigned.
• Interface with the hardware engineering team by understanding PCBA design, electrical schematics, and 3D product models.
• Work with internal and external partners, including marketing, systems engineering, project management, and QA/RA, to ensure project success.
• Draft requirements for external suppliers as necessary, ensuring alignment with project goals and standards.

• Bachelors or Masters degree in Software or Electronics Engineering, or a related discipline.
• Minimum of 3 years of experience, preferably 3-7 years, in Medical Devices R&D, with knowledge of FDA 21 CFR Part 820 and ISO 62304.
• Proficiency in developing and testing driver software (e.g., Nand Flash, SPI, I2C, UART, USB), and familiarity with firmware tools such as CROs and Logic Analyzers.
• Strong understanding of operating systems (Linux, Ubuntu), as well as native iOS, Android development, and web development technologies (MEAN, MERN stacks).
• Basic knowledge of JavaScript, React concepts, Node.js, and the regulatory frameworks related to medical device commercialization.
• Demonstrated project management skills, with an ability to adopt risk-based project execution strategies.
• Excellent communication skills, a proactive attitude, and a passion for product commercialization.
• Team player with strategic thinking, a go-getter attitude, and the ability to work under pressure.
• Strong interpersonal skills, capable of motivating, influencing, and sustaining networking relationships.

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