Key Responsibilities
- Design and develop catheter-based devices and components, including shafts, hubs, balloons, and delivery systems.
- Create and iterate prototypes using a variety of materials and fabrication techniques (e.g., extrusion, reflow, bonding, laser cutting).
- Conduct engineering testing (bench, simulated use, and environmental) and analyze data to inform design decisions.
- Develop and execute design verification and validation (DV&V) protocols and reports.
- Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Clinical teams.
- Support risk management activities, including hazard analysis and mitigation strategies.
- Generate and maintain design history file (DHF) documentation in compliance with regulatory requirements.
- Assist with process development and technology transfer to manufacturing.
- Troubleshoot product and process issues, perform root cause analysis, and implement corrective actions.
- Contribute to continuous improvement initiatives and engineering best practices.
Education & Experience
- Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field.
- Minimum 2+ years of experience in medical device R&D, preferably with catheter-based or minimally invasive devices
Technical Skills
- Hands-on experience with catheter design, materials, and manufacturing processes (e.g., polymers, braiding, coiling).
- Familiarity with test methods for catheter performance (e.g., tensile, burst, torque, trackability).
- Ability to interpret engineering drawings and apply GD&T principles.
- Experience with CAD software (e.g., SolidWorks or equivalent).
- Strong analytical and problem-solving skills with attention to detail
Regulatory & Quality Knowledge
- Basic understanding of FDA regulations (21 CFR Part 820) and ISO 13485.
- Familiarity with design controls, risk management (ISO 14971), and documentation practices.
Soft Skills
- Strong communication and teamwork skills.
- Ability to manage multiple projects and priorities.
- Proactive mindset with a willingness to learn and adapt.