R&D Engineering Manager en 4 C Medical Technologies

Description

POSITION SUMMARY

The R&D Engineering Manager will be a key member of the R&D team advancing 4C Medical’s transcatheter mitral valve replacement (TMVR) program. This position combines engineering expertise with clinical insight to translate medical needs into product design requirements.
 

The R&D Engineering Manager bridges the gap between engineering, clinical operations, and physicians, ensuring that design intent aligns with procedural performance and patient outcomes.

CORE RESPONSIBILITIES:

• 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 any case learnings findings with cross-functional teams (e.g., clinical, therapy development, regulatory, etc.) to ensure detailed procedural review, device performance and other analyses. 
• Proactively incorporate case learnings to training materials. 
• Assist with physician training and case observations to document procedural learnings and device behavior.
• Conduct pre-clinical and simulated-use testing to assess device performance and user interaction.
• Maintain familiarity with competitive technologies and clinical literature in structural heart interventions.
• Translate clinical and physician feedback into actionable product requirements and engineering specifications.
• Actively participate in the preparation of technical documentation, risk assessments, and regulatory submissions.
• Travel up to 10% (pre-clinical and clinical site support)

Requirements

Education

• B.S. in Biomedical, Mechanical, or related Engineering field (M.S./Ph.D. preferred)

Experience

• At least 5years of R&D, clinical development, or design engineering for cardiovascular systems

Technical Skills

• CAD proficiency (SolidWorks/ProE)
• Anatomical modeling (Materialise, Mimics)
• Statistical tools (Minitab), 
• Data analysis and management

Clinical Knowledge

• Working understanding of cardiovascular anatomy, hemodynamics, and transcatheter device procedures

Soft Skills

• Strong analytical ability
• Strong verbal and written communication skills
• Ability to effectively collaborate across multidisciplinary environments

Key Traits

• Analytical mindset and systems thinker with attention to procedural detail.
• Comfortable bridging R&D and clinical worlds.
• Adaptable and collaborative in fast-paced, iterative environments.
• Committed to innovation and patient-centered device development.