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

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  Lead and actively contribute to the product development process from concept generation through to commercialisation.
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  Participate in clinical trials or user evaluations to provide actionable feedback on device design.
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  Engage with end users to optimise product design and functionality.
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  Maintain product documentation and ensure compliance with quality standards, including risk management, design control, and design verification/validation.
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  Apply new and existing technologies to achieve optimal device design solutions.
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  Contribute to project planning and guide the team to deliver devices within budget, schedule, and technical requirements.
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  Mentor and support the professional development of team members.
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  Assist in the generation and protection of intellectual property arising from development activities.

Requirements

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  Bachelor's or Master's degree in Engineering, Science, or equivalent technical field.
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  5-8 years of experience in medical device product development, with proven experience leading development teams.
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  Experience coordinating and leading Design Reviews and compiling associated documentation.
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  Thorough knowledge of ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
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  Experience with catheter technology, design, testing, and manufacturing is a strong advantage.
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  Familiarity with engineering tools such as DOE, SPC, and statistical software (e.g., Minitab).
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  Working knowledge of biocompatible metals and/or polymers.
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  Willingness to travel occasionally to support project objectives.

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