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

- M.S. or Ph.D. in Mechanical Engineering, Biomedical Engineering, or a closely related discipline.

- 8+ years of experience in the design and development of interventional medical devices.

- Proven success in developing catheters, pacing leads, or delivery systems with complex geometries.

- Strong foundation in polymer science, braid design, extrusion technologies, and mechanical testing.

- Experience integrating patient-specific or population-based anatomical data into design processes.

- Proficient in CAD (SolidWorks, Creo) and FEA tools (ANSYS, Abaqus) for structural and stress analysis.

- Deep familiarity with catheter manufacturing techniques, including thermoplastic bonding and multi-lumen extrusion.

- Understanding of biocompatibility, sterilization, and regulatory compliance.

- Strong written and verbal communication skills, with ability to drive multidisciplinary collaboration.

Preferred Skills

- Experience developing pacing or electrophysiology catheters involving precision navigation and steerability.

- Exposure to anatomical data clustering and 3D path analysis tools.

- Hands-on experience with pilot manufacturing and design-for-manufacturing (DFM).

- Prior work in electromechanical catheter systems or lead delivery devices.

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.