
Chief Engineer of Medical Device Innovation
1 week ago
Electromechanical Medical Devices Engineering Lead
This opportunity involves leading the development of cutting-edge electromechanical interventional devices, taking projects from concept through to commercialization in a dynamic environment.
As an engineering lead, you will provide technical guidance, support the development of pioneering catheter-based technologies, and play a key role in shaping next-generation medical solutions.
Key Responsibilities:
- Develop electromechanical interventional devices while ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
- Engage with physicians and stakeholders to gather clinically relevant feedback and optimize product designs.
- Manage design history files, risk management files, and design verification/validation documentation.
- Apply advanced engineering tools such as DOE, SPC, and Minitab to support robust product development.
- Lead and participate in design reviews, ensuring comprehensive technical documentation.
- Mentor junior team members, fostering team development.
- Identify and implement new technologies to optimize device design, material selection, and manufacturing processes.
- Support intellectual property generation activities arising from R&D efforts.
Requirements:
- Level 8 degree in Engineering, Science, or a related discipline.
- 5+ years experience in medical device R&D, specifically in catheter development and electromechanical device design.
- Proven track record of leading design teams and coordinating cross-functional projects.
- Strong working knowledge of catheter technology, biocompatible materials (metal and polymer), and related testing/manufacturing processes.
- Availability for limited travel to support clinical trials and project milestones.
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