You will work closely with cross-functional teams to ensure compliance with industry standards while driving innovation and quality improvements
Job Title: Catheter Engineer
Location: AVA Technopark, Cote D'or
About Us:
Natec Medical is a leading global provider of medical device solutions, dedicated to improving patient care and outcomes worldwide. With a focus on innovation and excellence, we are at the forefront of the medical technology industry.
Position Overview:
As a Catheter Engineer, you will play a crucial role in designing, developing, and testing catheter-based medical devices. You will work closely with cross-functional teams to ensure compliance with industry standards while driving innovation and quality improvements.
Key Responsibilities:
- Design and develop catheter-based medical devices in compliance with FDA, ISO 13485, and industry regulations.
- Conduct feasibility studies, prototyping, and validation, testing and transfer to manufacturing of medical devices
- Design and product development of products through Design Freeze, DV&V and TTM
- Develop and execute test protocols for mechanical and functional performance.
- Collaborate with manufacturing teams to optimize product design for scalability and yield
- Resolve design and production challenges to ensure product reliability.
- Maintain technical documentation and support regulatory compliance.
- Stay updated on the latest catheter technologies and industry advancements.
Requirements:
- Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
- 3+ years of experience in catheter development (preferred experience in PTA/PTCA catheter development) and in an FDA and ISO 13485- regulated environment
- knowledge of polymer materials, extrusion, bonding techniques, and catheter testing.
- Proficiency in CAD software (e.g., SolidWorks) and Minitab tools.
- Understanding of hydrophilic and hydrophobic coatings for catheters.
- Understanding of risk management (ISO 14971) and design control principles.
- Excellent problem-solving, project management, and communication skills.
If you meet these qualifications and are excited about joining a dynamic team dedicated to making a difference in healthcare, please submit your resume and cover letter.
Deadline for Applications: 21st April 2025
Natec Medical is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.