Job Description
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.
The Role
Reporting to the Director, Clinical & Systems Engineering, the Senior Systems Engineer will play a critical role in advancing BrioHealth’s implantable heart pump platform (BrioVAD) and next-generation mechanical circulatory support (MCS) technologies.
This individual will own key elements of systems engineering across the full product lifecycle from early concept through clinical validation and regulatory approval, ensuring robust, traceable, and compliant system design in a Class III medical device environment.
What You’ll Do
- Lead systems engineering activities across new product development and design changes, including requirements definition, architecture, verification/validation, and design traceability
- Translate user and clinical needs into system requirements, ensuring alignment with intended use, safety, and regulatory expectations
- Drive system-level design and integration, partnering cross-functionally with hardware, software, and clinical teams
- Own design inputs/outputs including user needs, system requirements, specifications, and traceability matrices
- Lead and/or support verification & validation strategy and execution, including protocol development, testing, and reporting aligned with FDA and EU MDR expectations
- Support regulatory submissions (PMA/IDE/CE Mark) by generating high-quality design documentation and responding to regulatory feedback
- Contribute to clinical readiness and execution, including support of ongoing FDA and EU MDR clinical trials for the BrioVAD system
- Ensure compliance with design controls and quality systems, including risk management (ISO 14971) and documentation within controlled environments
- Influence cross-functional decision-making, using data and systems-level thinking to drive alignment across R&D, Clinical, Quality, and Regulatory
- Identify and mitigate system-level risks, ensuring safe and effective product performance in a highly regulated environment
What You Bring
- 5+ years of systems engineering experience in medical device development, ideally within Class II/III or implantable technologies
- Proven experience owning systems engineering deliverables within a regulated design control environment
- Demonstrated success supporting FDA (PMA/IDE) and/or EU MDR submissions
- Strong experience with requirements development, traceability, and V&V execution
- Hands-on experience authoring test protocols, reports, and design documentation used in regulatory submissions
- Solid understanding of:
- 21 CFR 820 / FDA QMSR
- ISO 13485
- ISO 14971 (Risk Management)
- Experience working within controlled document systems (e.g., PLM, eQMS)
- Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, Computer Science, or related field (advanced degree preferred)
- Strong communication skills with ability to operate effectively in a cross-functional, global environment