Our esteemed client, a pioneering medical technology firm revolutionizing solid organ transplantation for individuals grappling with end-stage heart, lung, and liver failure, is in search of a proficient and ambitious Senior Software Engineer to augment our team. Reporting directly to the Director of Software Development, the chosen candidate will play a pivotal role in shaping the life cycle of embedded software applications crucial for preserving donated hearts, lungs, livers, and other vital organs on our cutting-edge Organ Care System (OCS™).

Responsibilities:

• Collaborate with stakeholders to discern software requirements and conduct risk analysis for novel applications.
• Conceptualize, execute, rigorously test, and meticulously document embedded software.
• Develop and execute software unit and system test plans and procedures.
• Formulate and uphold software development protocols in compliance with regulatory standards, including FDA guidance and IEC 62304.
• Oversee procedures and deliverables for software verification.
• Investigate field complaints to ascertain root cause and implement requisite corrective measures.
• Provide support for quality audits and contribute to the preparation of FDA submissions.
• Fulfill other duties and tasks within the purview of my client as necessary.

Requirements:

• Bachelor’s or Master’s degree in Software Engineering, Electrical Engineering, or equivalent.
• A minimum of 8 years of relevant experience in real-time embedded software development within a Class II or Class III FDA regulated environment.
• Proficiency in C and C programming languages.
• Preferred experience in device driver level development (e.g., UART, I2C, SPI, ADC, BT, USB OTG) and ARM Processor and PIC microcontroller development.
• Familiarity with RTOS (e.g., QNX RTOS or equivalent).
• Competence with standard embedded development and debugging tools (e.g., GNU, Momentics, JTAG) and Configuration Management and Project Tools (e.g., Git, JIRA, Scripts, Labview).
• Knowledge of CI/CD build environment infrastructure is advantageous.
• Integration experience with testing, static analysis, and security frameworks is a plus.
• Must exhibit strong teamwork skills and possess exceptional interpersonal and communication abilities, both written and verbal.
• Attention to detail and exceptional organizational skills are imperative.
• Join us in our pursuit of excellence at the forefront of the burgeoning multi-billion-dollar medical device industry dedicated to transforming organ transplantation.

If you or anyone you know is interested please reach out to Noah Pabarja at n.pabarja@engtal.com