Senior Mechanical Engineer - Anatomically Optimized Catheter Development

Job Description

Job Description

We are a fast-growing medical device company developing advanced Software as a Medical Device (SaMD) solutions for interventional cardiology and structural heart procedures. Our flagship technology integrates real-time fluoroscopy with pre-procedure 3D CT annotations to provide precise intra-procedural guidance, enhancing safety and clinical outcomes.

Our innovation combines CT preprocessing, fluoroscopy preprocessing, AI-driven detection and tracking, anatomical landmark detection, and personalized DRR-based network training with cutting-edge registration protocols. We operate with a small, highly skilled in-house engineering team, supplemented by specialized contractors across several continents.

We are seeking a highly experienced Mechanical Engineer to lead the design and development of a new family of catheters optimized for complex anatomical pathways. The role integrates deep mechanical design expertise with data-driven anatomical insights derived from large-scale CT imaging studies across diverse patient populations.

Key Responsibilities

• Lead the mechanical and material design of anatomically guided catheters using population-level CT-derived path data.
• Collaborate with imaging scientists and data engineers to interpret anatomical clustering models and translate them into geometric design parameters.
• Apply comparative material knowledge from similar devices to select optimal polymers, braiding structures, and reinforcement patterns.
• Develop and execute bench testing, mechanical validation, and durability protocols to evaluate torque response, flexibility, and navigation performance.
• Interface with process engineers to transition prototypes to pilot manufacturing, ensuring scalability and reproducibility.
• Integrate design feedback from clinicians to refine ergonomic and procedural usability.
• Maintain full compliance with medical device design control standards, including risk analysis (ISO 14971), V&V documentation, and traceability under ISO 13485.
• Collaborate cross-functionally with clinical, quality, and regulatory teams to support Class II / III medical device filings.

Qualifications

Preferred Skills

We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.