Electromechanical Device Development Leader
3 days ago
This is a highly rewarding opportunity for an experienced Senior R&D Engineer to lead the design and development of innovative electromechanical medical devices.
Key Responsibilities:- Contribute to product development from concept generation through to commercialisation, applying expertise in engineering principles and technologies.
- Participate in clinical trials or user evaluations to provide actionable feedback on device design and functionality.
- Engage with end-users to optimise product design and ensure it meets their needs.
- Maintain accurate product documentation and ensure compliance with quality standards, such as ISO 13485 and FDA 21 CFR Part 820 Design Control requirements.
- Stay up-to-date with the latest technologies and apply them to achieve optimal device design solutions.
- Contribute to project planning and guide the team to deliver devices within technical requirements, ensuring timely completion and high-quality results.
- Mentor and support the professional development of team members, helping them grow in their roles.
- Assist in the generation and protection of intellectual property arising from development activities, including patents and trade secrets.
- Bachelor's or Master's degree in Engineering, Science, or equivalent technical field.
- 5-8 years of experience in medical device product development, with proven experience leading development teams.
- Experience coordinating and leading Design Reviews and compiling associated documentation.
- Thorough knowledge of quality standards and regulatory requirements.
- Familiarity with engineering tools, such as DOE, SPC, and statistical software.
- Working knowledge of biocompatible materials and manufacturing processes.
- Willingness to travel occasionally to support project objectives.
This role offers the opportunity to work on cutting-edge projects, develop your skills, and make a real impact in the medical device industry. If you are passionate about innovation and leadership, this could be the perfect fit for you.
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