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R&D Engineering Manager
2 weeks ago
Job Type
Full-time
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)
Education
- B.S. in Biomedical, Mechanical, or related Engineering field (M.S./Ph.D. preferred)
- At least 5years of R&D, clinical development, or design engineering for cardiovascular systems
- CAD proficiency (SolidWorks/ProE)
- Anatomical modeling (Materialise, Mimics)
- Statistical tools (Minitab),
- Data analysis and management
- Working understanding of cardiovascular anatomy, hemodynamics, and transcatheter device procedures
- Strong analytical ability
- Strong verbal and written communication skills
- Ability to effectively collaborate across multidisciplinary environments
- 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.
Salary Description
$115,000 to $155,000 (DOQ)
