JOB DESCRIPTION

In this unique and exciting role, you will be responsible for the technical support 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 of the technology (and into commercialization). This position will play a key role in pre-clinical and clinical studies of the device and 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.

Responsibilities

1. 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.
• Work closely with R&D to 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 the company’s leading clinical expert in its heart failure products (form clinical trial to early and late commercial phases of the product lifecycle)

2. 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.

3. 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.

Requirements

• Bachelor’s degree in biomedical engineering or a related field plus 8 or more years of experience (or an advanced degree (master’s plus 5 years experience) is strongly preferred.
• Extensive experience in biomedical engineering and/or clinical science, with a focus on class 3 medical devices. Areas of expertise may include active implantable life sustaining medical devices, surgical tools, OR experience, and direct patient experience.
• 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 strongly preferred.