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 enable chronic MCS therapy to be accessible to more patients across the globe.
The Role
The Field Clinical Engineer serves as a key technical and clinical resource supporting BrioHealth's mechanical circulatory support systems throughout the clinical trials and future commercial activities.
This role combines engineering, clinical support, and data analysis to monitor device performance, troubleshoot technical issues, and provide timely guidance to physicians, VAD coordinators, and hospital staff. This position is well suited for individuals who enjoy combining engineering analysis, clinical physiology, and problem-solving to improve outcomes for patients supported with advanced mechanical circulatory support systems.
What You’ll Do
Provide remote and on-site technical support for BrioHealth's mechanical circulatory support systems, including participation in a 24/7 rotating on-call support program. Analyze device log files, alarms, pump waveforms, and system performance data to identify clinically meaningful changes in patient-device interaction.Troubleshoot hardware, software, and system issues remotely and during on-site clinical support. Monitor longitudinal device performance trends and identify changes related to patient-device interaction, pump function, and alarm conditions. Partner closely with R&D to expand product knowledge, improve system performance, and deepen understanding of device behavior under varying physiological conditions. Document technical findings, field observations, complaint trends, and product performance data to support continuous product improvement. Support clinical trial activities, including implant procedures, hospital-based patient support, and study execution in compliance with study protocols, regulatory requirements, and quality standards. Deliver product training and technical education to physicians, clinical staff, investigators, and internal teams. Support field activities including software updates, troubleshooting, hospital visits, and clinical site support as needed. Assist with complaint investigations by analyzing device performance data, evaluating returned products, and supporting root cause investigations.Develop deep technical expertise in BrioHealth's heart failure therapies and serve as a trusted product expert throughout the clinical and commercial product lifecycle.What You Bring
Bachelor's degree in Biomedical Engineering or a related engineering discipline required; Master's degree preferred. 2+ years of relevant engineering, clinical, or medical device experience preferred. Experience interpreting technical system performance data and correlating device behavior with patient-specific clinical conditions. Strong analytical, troubleshooting, and problem-solving skills with the ability to interpret complex technical and clinical data. Excellent communication and interpersonal skills with the ability to effectively collaborate with physicians, clinical teams, engineers, and cross-functional stakeholders. Ability to work independently in a fast-paced environment requiring sound judgment and timely decision-making. Willingness to participate in a 24/7 rotating on-call schedule. Ability to travel up to 25% for clinical support, physician training, and internal meetings.Preferred QualificationsExperience supporting implantable cardiovascular devices, ventricular assist devices (VADs), mechanical circulatory support systems, or other Class III implantable medical devices. Understanding of cardiovascular physiology, hemodynamics, and heart failure management. Experience supporting physicians and clinical teams in cardiac surgery, ICU, heart failure, or mechanical circulatory support environments. Experience working within FDA-regulated medical device environments, including complaint handling, quality systems, and post-market support. Read LessAbout 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.
The role
Reporting to the Senior Manager, Software Engineering, the Senior Software Engineer will play a key role in developing and evolving software solutions that support the BrioVAD® platform. This position combines enhancement of existing Windows-based applications with development of next-generation cloud-connected solutions that support remote patient monitoring, clinical workflows, and data-driven decision making. The ideal candidate brings strong expertise in C#/.NET development, cloud technologies, and modern software architecture, with the ability to contribute across the full software development lifecycle.
What You’ll Do
Design, develop, and maintain software applications supporting the BrioVAD platform using C# and .NET technologies. Enhance and modernize existing Windows-based applications while supporting migration toward contemporary software architectures and user interfaces. Develop cloud-connected solutions and services that enable remote monitoring, secure data access, and clinician-facing workflows. Contribute across the full technology stack, including desktop applications, APIs, backend services, cloud infrastructure, and web-based components. Design and implement user interfaces that support visualization of clinical and device data, including graphs, waveforms, and real-time system information. Diagnose and resolve performance, scalability, and reliability challenges within multithreaded applications. Apply cybersecurity, privacy, and data protection best practices to software systems handling sensitive healthcare information. Collaborate closely with Systems, Electrical, Mechanical, Quality, Regulatory, and Clinical Engineering teams throughout product development. Follow established software development processes, design controls, and documentation standards. Develop and maintain automated tests while contributing to software quality and verification activities. Support key product development milestones with a focus on reliability, maintainability, and regulatory compliance.What You Bring
Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related discipline. 5+ years of professional software development experience using C# and .NET. Experience developing Windows-based applications, including WinForms and/or modern UI frameworks. Hands-on experience building cloud-connected applications using Azure or AWS. Experience developing backend services, APIs, and distributed systems. Strong understanding of multithreaded application design, performance optimization, and debugging techniques. Experience working within collaborative cross-functional development environments. Strong communication, documentation, and problem-solving skills. Ability to work onsite in Burlington, MA at least three days per week.Preferred Qualifications
Experience developing software for regulated industries such as medical devices, healthcare, aerospace, or life sciences. Experience with modern Windows UI frameworks including WPF, WinUI, or .NET MAUI. Experience working with real-time or near real-time data processing, telemetry, or waveform visualization. Familiarity with cloud security, secure system design, and healthcare data privacy requirements. Experience with CI/CD pipelines and modern DevOps practices. Exposure to analytics, machine learning, or AI-enabled software applications. Read LessAbout 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.
The Role
Reporting to the Senior Manager, Hardware Engineering, the Staff/Principal Mechanical Engineer will play a key technical role in the design, development, and advancement of complex Class III implantable medical devices and supporting technologies.
The individual will contribute across multiple areas of mechanical engineering including system architecture, structural and reliability engineering, fluid-contacting components, thermal management, subsystem integration, and product development execution.
The ideal candidate brings strong experience developing regulated medical devices within cross-functional environments and can drive technical problem solving from concept through verification, validation, and manufacturing transfer. This role will collaborate closely with Systems, Electrical, Software, Manufacturing, Quality, Regulatory, and Clinical teams to develop safe, reliable, and scalable products.
This is a highly visible technical role with significant influence on product architecture, engineering execution, and long-term technology development.
What You’ll Do
Lead and contribute to the design and development of complex mechanical systems and components for Class III medical devices. Support/drive mechanical architecture development, subsystem integration, and product optimization activities across the product lifecycle. Translate user needs, system requirements, and clinical inputs into robust engineering solutions. Support/drive technical problem solving related to performance, reliability, manufacturability, and product scalability. Partner cross-functionally with Electrical, Systems, Software, Manufacturing, Quality, Regulatory, and Clinical teams throughout development activities. Support risk management activities including DFMEA, PFMEA, root cause investigations, and mitigation planning. Contribute to verification and validation activities including mechanical testing, reliability testing, environmental testing, and failure analysis. Support Design History File (DHF) documentation, engineering reviews, and regulatory submissions. Apply Design for Manufacturability (DFM), Design for Assembly (DFA), and tolerance analysis principles to product development efforts. Support manufacturing process development, design transfer, and production readiness activities as needed. Stay current on emerging technologies, materials, manufacturing methods, and engineering tools relevant to implantable medical devices.What You Bring
BS in Mechanical Engineering or related discipline required; advanced degree preferred. 8+ years of experience developing FDA-regulated medical devices or other highly regulated products. Experience contributing to the design and development of complex mechanical systems within cross-functional engineering environments. Strong understanding of mechanical engineering fundamentals including structural analysis, reliability engineering, materials selection, and tolerance analysis. Experience with CAD tools such as SolidWorks, Creo, or NX. Familiarity with engineering analysis tools such as FEA and/or CFD is preferred. Working knowledge of applicable medical device standards and regulations including ISO 13485, ISO 14971, and design control requirements. Experience supporting verification, validation, and engineering test activities. Strong communication, collaboration, and technical documentation skills. Ability to operate effectively in a fast-paced, evolving, and highly collaborative environment. Implantable and/or cardiovascular medical device experience is preferred but not required. Willingness to travel up to 10% as needed.