Senior Manager, Software Engineering

Job Description

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.

Responsibilities

Lead and mentor a multidisciplinary team of software engineers, providing technical guidance, supporting career development, and fostering a collaborative, innovative culture centered on engineering excellence, accountability, and high-quality outcomes.

Oversee the seamless integration of software components across hardware platforms, mobile apps, and web applications supporting ventricular assist devices (VADs) for patients with advanced heart failure.

Drive the implementation of robust quality processes, including automated testing, validation, and verification, ensuring compliance with FDA regulations and ISO 13485 standards.

Ensure software design and development adhere to medical device industry standards, including ISO 14971 (risk management), IEC 62304 (software life cycle processes), IEC 62443 (cybersecurity), and safety-critical system best practices.

Partner with the regulatory team to support submission activities and help secure necessary approvals for Class II and Class III medical devices.

Participate in internal and external audits, ensuring full compliance with applicable regulatory standards and documentation requirements.

Contribute to comprehensive risk management efforts, including hazard analysis, FMEA, and the implementation of design controls and mitigation strategies related to software functionality, user interfaces, and potential failure modes.

Collaborate cross-functionally with electrical, systems, and mechanical engineering teams to ensure cohesive system integration. Coordinate with external partners, consultants, and vendors to meet project milestones and deliverables.

Maintain clear, consistent communication with regulatory, quality assurance, and clinical teams to ensure alignment on technical specifications and broader project objectives.

Champion software development best practices, including agile methodologies, version control, automated testing, and CI/CD pipelines. Identify and implement process improvements to drive efficiency, product quality, and regulatory compliance throughout the software development lifecycle.

Qualifications

Bachelor’s degree in Software Engineering, Computer Science, or a related technical field; advanced degree preferred.

8+ years of software engineering experience, with a strong emphasis on embedded systems development.

Minimum of 3 years in a leadership or management role within the medical device or healthcare industry, overseeing complex product development projects from concept through commercialization.

Proven track record of leading high-performing software engineering teams, driving cross-functional project execution, and delivering products on time and within scope.

Deep understanding of the full software development lifecycle (SDLC), including architecture, design, development, verification, validation, release, and post-market support.

Hands-on experience with software development for Class II and Class III medical devices, including working knowledge of design controls, documentation, and risk management practices.

Expertise in embedded systems programming, including real-time operating systems (RTOS), custom hardware integration, and firmware development.

Familiarity with multi-platform integration, including embedded systems, mobile applications (iOS/Android), and full-stack web development environments.

Strong working knowledge of regulatory standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 (SDLC), ISO 14971 (Risk Management), IEC 60601 (Safety), and IEC 62443 (Cybersecurity).

Skilled in root cause analysis and applying objective, data-driven engineering techniques to resolve complex system-level issues.

Proficient in scripting and automation, including the development of automated test scripts on Windows or Linux platforms using Python, C, or similar languages for hardware and system testing.

Demonstrated success working in fast-paced, startup or growth-stage R&D environments, with a global team dynamic and rapidly evolving priorities.

Strong communication and interpersonal skills, with the ability to effectively collaborate across engineering, regulatory, quality, and clinical teams.

Excellent technical documentation and reporting abilities, with a focus on clarity, regulatory compliance, and stakeholder communication.

Full-time