Sr. Clinical R&D Engineer

BrioHealth Solutions Inc. is seeking a highly skilled and motivated individual to join our team as a Senior Clinical R&D Engineer. In this unique and exciting role, you will be responsible for guiding the development of Mechanical Circulatory Support systems and their interaction with the patient, caregivers, and clinicians. You will collaborate with cross-functional teams, including physicians, researchers, engineers, sales, and marketing, to develop the tools and experience necessary to guide and support product development activities ranging from early-stage research to early clinical use, and into commercialization. This position will play a key role in pre-clinical and clinical studies of the device and the candidate must be comfortable with working in both engineering areas as well as in the operating room or ICU. The ideal candidate will have a strong engineering background or degree with a deep understanding of the clinical science and management of heart failure and cardiac surgery.Join our team and play a pivotal role in shaping the success of our R&D programs and associated pre-clinical and clinical trials. If you are a clinical expert and engineering leader with a passion for patients, physicians, and technology, we invite you to apply.

Responsibilities

Clinical Study:

• Participate in the execution of clinical trials related to heart failure devices, including mechanical circulatory assist devices, ensuring adherence to regulatory requirements, ethical guidelines, and industry best practices.
• Develop, document, and maintain a detailed understanding of the product as it relates to the biology/physiology (e.g., flow waveforms resulting from various patient conditions, pump speeds, log file analysis, etc.) of the patient and associated clinical team (surgeon, cardiologist, VAD Coordinator) and caregivers.
• Participate in and support clinical trial training including the execution of testing and analysis and development of training materials related to the operation of the system and interaction with the end users of the product.
• Support clinical trial sites through frequent on-call technical support and troubleshooting, occasional attendance at implantation cases, and infrequent emergent clinical guidance.
• Become a company clinical expert in its heart failure products (form clinical trial to early and late commercial phases of the product lifecycle)

Pre-Clinical Study:

• Plan and execute pre-clinical research studies considering the potential product and marketing claims, ultimate clinical implications, and limitations of in-vivo and in-vitro study models.
• Collaborate with internal/external experts in biology, physiology, hemocompatibility, animal model development, and other relevant scientific and engineering disciplines to define study objectives, design protocols, and execute pre-clinical projects.
• Identify and select appropriate research and pre-clinical study sites, investigators, and test models for execution of external research and evaluation.

Research & Development:

• Contribute to the development and improvement of heart failure devices through the investigation of clinical insights and user feedback into the product design process.
• Define clinical performance criteria and requirements to enable accurate interactions between the devices and patient physiology.
• Stay up to date on the latest developments in heart failure treatment, technologies, regulations, and research methodologies to enhance the team's knowledge and help guide research strategies.
• Apply engineering principles and modeling / analytical techniques to optimize device performance, usability, and reliability.
• Participate in systems engineering projects related to architecture, requirements, or performance of medical systems with a focus on human/device interaction.
• Collaborate with external partners, key opinion leaders, and clinical experts to gather input, feedback, and insights to inform product development projects.
• Create and document unique intellectual property.

Team Culture:

• Foster a culture of high performance, collaboration, and continuous learning within the team.
• Work cross-functionally to provide technical and clinical expertise.

Requirements

• Bachelor’s degree in biomedical engineering or a related field plus 7 or more years of experience, or an advanced degree (master’s plus 5 years of experience) is strongly preferred.
• Extensive experience in biomedical engineering and/or clinical science, a focus on medical device development is desired. Areas of expertise may include active implantable life sustaining medical devices, Systems Engineering, surgical tools, communication systems (patient and system clinical data), power system, and data analytics.
• Expected behavioral qualities include a positive outlook and affinity for teamwork, logic, innovation, initiative, influence, and self-sufficiency.
• Excellent communication and stakeholder management abilities, with the capability to interact with individuals at all levels of the organization.
• Strong understanding of implantable devices (Mechanical Circulatory Support Devices Preferred), medical imaging, cardiovascular anatomy and physiology, and heart failure.
• Strong analytical and problem-solving skills, with the ability to collect, analyze, and interpret engineering and clinical data accurately.
• Experience in a regulated industry (and especially knowledge of the FDA Quality System Regulation) is required. Familiarity with issues surrounding the design and production of medical electronics, as well as cardiovascular physiology, pathophysiology, and the biologic interface of a mechanical device is required.

About BrioHealth Solutions Inc

BrioHealth Solutions Inc., is an advanced medical device company dedicated to the research, development, and commercialization of a miniaturized implantable ventricular assist system (CH-VAD®) featuring total magnetic suspension (TMS) for the treatment of end-stage chronic heart failure. With offices in the U.S. and China, we are growing our U.S. team in preparation for clinical studies and regulatory approval in the U.S. and Europe.