Position: Senior R&D Engineer
Position Summary
The Senior R&D Engineer will lead the design and development of electromechanical medical devices, providing technical leadership and maintaining the Design History File (DHF) and associated documentation throughout the product lifecycle.
Key Responsibilities
1. Lead and actively contribute to the product development process from concept generation through to commercialisation.
2. Participate in clinical trials or user evaluations to provide actionable feedback on device design.
3. Engage with end users to optimise product design and functionality.
4. Maintain product documentation and ensure compliance with quality standards, including risk management, design control, and design verification/validation.
5. Apply new and existing technologies to achieve optimal device design solutions.
6. Contribute to project planning and guide the team to deliver devices within budget, schedule, and technical requirements.
7. Mentor and support the professional development of team members.
8. Assist in the generation and protection of intellectual property arising from development activities.
Requirements
9. Bachelor's or Master's degree in Engineering, Science, or equivalent technical field.
10. 5-8 years of experience in medical device product development, with proven experience leading development teams.
11. Experience coordinating and leading Design Reviews and compiling associated documentation.
12. Thorough knowledge of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
13. Experience with catheter technology, design, testing, and manufacturing is a strong advantage.
14. Familiarity with engineering tools such as DOE, SPC, and statistical software (e.g., Minitab).
15. Working knowledge of biocompatible metals and/or polymers.
16. Willingness to travel occasionally to support project objectives.
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