Research and Development Engineer

THE OPPORTUNITY:

4C Medical Technologies, Inc. is engineering a first-in-class Transcatheter Mitral Valve Replacement (TMVR) system to redefine care for patients with mitral regurgitation. We seek a highly motivated R&D Engineer to focus on gathering clinical feedback in order to troubleshoot issues and improve the efficiency and effectiveness of our therapy. This position combines engineering expertise with clinical insight to translate medical needs into product design requirements.

The ideal candidate will bridge the gap between engineering and clinical operations, to ensure design intent aligns with procedural performance and patient outcomes. At 4C Medical, the distance between your insight and its impact on a patient is short.

• Analyze product performance data as well as clinical and anatomical data relevant to procedural parameters with the goal of continuous improvements in procedural steps and product design optimizations.
• Lead gathering and evaluation of case findings with cross-functional teams (e.g., clinical, therapy development, regulatory, etc.) to ensure detailed review of procedures, device performance and other analyses.
• Facilitate the incorporation of case learnings to procedural documentation and training materials.
• Conduct pre-clinical, simulated-use and usability testing to assess device performance and user interaction. Lead Human Factors Engineering (HFE) efforts.
• Maintain familiarity with competitive technologies and clinical literature in structural heart interventions.
• Translate clinical and physician feedback into actionable product requirements and engineering specifications.
• Support test method development, fixture design, test method validation and execution of critical testing.
• Actively participate in the preparation of technical documentation, risk assessments, and regulatory submissions.
• Travel up to 10% (pre-clinical and clinical site support)

EDUCATION & EXPERIENCE:

• B.S. in Biomedical, Mechanical, or related Engineering field (M.S./Ph.D. preferred)
• At least 5 years of R&D or design engineering for cardiovascular medical devices.
• 3+ years of experience with structural heart or other class III medical devices preferred.
• Experience in a pre-commercial start up environment preferred.

• CAD proficiency (Solid Works/ProE)
• Anatomical imaging (fluoroscopy, echocardiography) modeling (Materialise, Mimics)
• Systems and Human Factors Engineering (HFE)
• Statistical tools (Minitab)
• Data management
• Working understanding of cardiovascular anatomy, physiology, and transcatheter device procedures

• Strong analytical ability driven by an analytical mindset, systems thinking and attention to procedural detail
• Strong verbal and written communication skills
• Ability to effectively collaborate across multidisciplinary environments
• Comfortable bridging R&D and clinical worlds.
• Adaptable and collaborative in fast-paced, iterative environments.
• Committed to innovation and patient-centered device development.