About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

Reporting to the VP of R&D, Software Engineering, BrioHealth Solutions, Inc. is seeking an experienced Embedded Software Engineer with a proven track record in software development for Class II or III medical devices to join our R&D team. The successful candidate will play a critical role in the development of IEC 62304 compliant medical device software for new products as well as add improvements to the existing product line.

In addition, this person will help triage and fix software defects, support software verification testing, and participate as needed in efforts related to the clinical trial of our BrioVAD implantable heart pump and related mechanical circulatory support (MCS) technologies. This is a broad role, where collaboration with cross-functional teams, including hardware and system engineering, quality assurance and regulatory affairs will be necessary to deliver robust and reliable software solutions.

Responsibilities

• Contribute to the design, development, testing, and maintenance of embedded software for Class III medical devices for new products and sustaining activities on post market products.
• Participate in risk assessments and ensure risk management processes are followed throughout the software development lifecycle.
• Provide technical leadership and mentorship to junior software engineers, fostering a collaborative and innovative development environment.
• Write clean, efficient, and well-documented code.
• Conduct code reviews and ensure compliance with internal SOPs, best practices, and adherence to regulatory requirements and industry standards (e.g., IEC 62304 SDLC, ISO 13485 Quality Management System, ISO 14971 Risk Management, etc.).
• Conduct and oversee the thorough testing and debugging of software to ensure functionality, reliability, and performance.
• Perform software verification and validation activities, including unit testing, integration testing, and system testing.
• Create and maintain comprehensive software documentation, including software requirements, design specifications, and test plans.
• Collaborate closely with hardware, systems, and clinical engineers, and other cross-functional team members to integrate software with hardware components.
• Ensure that all software development activities comply with relevant regulatory standards and guidelines.
• Collaborate with quality assurance and regulatory affairs teams to prepare and submit documentation for regulatory approvals.
• Stay up to date with industry trends, emerging technologies, and best practices in embedded software development and medical device regulations.
• Introduce innovative solutions to enhance the performance, reliability, and capability of our software products.

Requirements

• Minimum of a BS degree in Electrical Engineering, Software Engineering, Computer Science, or a closely related field.
• Minimum of 3 years of experience in software development for medical devices, with a focus on class-2 and class-3 devices.
• Strong understanding of IEC 62304 and other relevant standards (ISO 13485, ISO 14971, etc.).
• Proficiency in programming languages such as C, C++ and Python.
• Familiarity with embedded systems, communication protocols, and real-time operating systems.
• Knowledge of software development methodologies and best practices, including unit and integration test frameworks.
• Experience with software development tools (IDEs, version control, issue tracking).
• Familiarity with cybersecurity principles in the context of medical device software.
• Ability to make critical judgments and decisions to understand root causes of technical problems encountered and execute thorough completion of documentation associated with work product.
• Strong interpersonal, communication, and technical writing skills, including the ability to build cross-functional relationships across the organization where tact, persuasive skills and an understanding of negotiation are required to gain support.
• Up to 10% travel may be required.