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

BrioHealth Solutions is seeking a Senior Software Engineering Manager to lead our software team within the growing R&D organization. This critical leadership role will drive the development of software for the BrioVAD implantable heart pump and other advanced mechanical circulatory support (MCS) technologies. These solutions span embedded software on custom hardware as well as mobile and web applications designed to support patients living with end-stage heart failure.
As Senior Software Engineering Manager, you will collaborate closely with cross-functional partners in mechanical and electrical engineering, regulatory affairs, quality assurance, and clinical affairs to bring innovative, life-saving medical technologies to market. You will be responsible for ensuring the delivery of high-quality, compliant software solutions that meet stringent regulatory requirements and enhance patient outcomes. This is a high-impact role for a technically proficient and mission-driven leader who thrives in a fast-paced, collaborative environment. You will be instrumental in shaping the future of our software strategy, team culture, and engineering excellence.

QUALIFICATIONS

• Minimum of a bachelor’s degree in software engineering or related field.
• Minimum of 8+ years of experience in software engineering with a focus on embedded development, with at least 3 years in a management role within the medical device or healthcare industry leading complex product development projects.
• Proven track record of managing software engineering teams, driving project execution, and achieving key milestones.
• Solid understanding of software development lifecycle processes, including design, development, verification, validation, and release management.
• Demonstrated experience in developing software for Class 2 or Class 3 medical devices. Excellent problem-solving, analytical, and debugging skills.
• Strong experience with embedded systems, real-time operating systems (RTOS), and custom hardware design. Familiarity with advanced hardware/software integration techniques for embedded systems, phone apps, and full stack web development.
• In-depth knowledge of medical device regulations, including FDA 21 CFR Part 820, ISO 13485, IEC 62304, and IEC 60601.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across teams and with stakeholders.
• Ability to thrive in a fast-paced, startup environment with a focus on delivering high-quality results under tight deadlines.
• Experience with using best-practice root cause analysis techniques backed by objective and data-driven engineering analysis
• Familiarity with regulatory and compliance standards such as IEC 60601.
• Ability to write and develop automated test scripts using Windows or Linux OS, with experience writing or using Python/C for hardware testing and automation
• Demonstrated ability to work in a collaborative and fast-paced R&D environment with global team members
• Excellent written and verbal communication skills, with experience producing technical documentation.

• Lead and mentor a multidisciplinary team of software engineers, guiding the team through technical challenges and career growth while fostering a collaborative and innovative environment that encourages engineering excellence and adheres to deadlines and quality standards.
• Ensure seamless integration of software components across hardware platforms and phone and web applications supporting ventricular assist devices for heart failure patients.
• Drive the implementation of quality control processes, including automated testing, validation, and verification, in line with FDA and ISO 13485 standards.
• Ensure software design and development follows industry standards for medical devices, including risk management (ISO 14971), cybersecurity (IEC 62443), IEC 62304 (SDLC) and safety-critical systems.
• Interface with our regulatory team to help support the submission process to obtain necessary approvals. Participate in internal and external audits, ensuring compliance with all regulatory requirements and standards for Class 2 and Class 3 medical devices.
• Contribute to risk management processes, including hazard analysis, FMEA (Failure Modes and Effects Analysis), design controls for software systems, and mitigation efforts related to software failures, user interfaces, and overall product functionality.
• Collaborate with other engineering disciplines (electrical, systems, etc.) to ensure seamless integration of software components into the overall system, and with external vendors, consultants, and partners to ensure the timely delivery of product components.
• Communicate effectively with cross-functional teams including regulatory, quality assurance, and clinical to ensure alignment on technical and non-technical requirements.
• Champion best practices in software development, including agile methodologies, version control, automated testing, and continuous integration/delivery (CI/CD). Identify and implement process improvements to enhance efficiency, quality, and compliance within the software development lifecycle.