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As part of the Design Engineering team, the Senior Design Engineer will lead and be an integral part of a team developing a portfolio of platform delivery system products. This position requires a candidate with significant product development experience in the medical device arena, and one who will be comfortable leading and developing a team. She/he will report to the Group Leader.
- Lead and be an integral part of the team tasked with the development process from concept generation through to design verification.
- Assist in the development of intellectual property generated by development activities.
- Ensure the application of new and existing technologies to provide the optimum delivery system design.
- Participate in trials with physicians to provide clinically relevant feedback on product designs.
- Provide technical feedback during frequent technical contact with customers to optimise product design.
- Support the maintenance of product files and other relevant documentation to comply with quality standards.
- Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines.
- An engineering, science or equivalent degree.
- 5 to 8 year’s industry experience in a medical product development environment with a proven track record of leading teams in device development.
- Experience of coordinating and leading Design Reviews and the compilation of associated documentation.
- Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.
- Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
- Proven experience of minimally invasive Medical Device design, development and manufacturing.
- Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes. Knowledge and experience with Medical Device sterilisation processes, specifically gamma and EtO sterilisation.
- Proven experience of work with catheter technology, catheter design and testing and catheter manufacturing a distinct advantage.
- Experience with engineering tools such as DOE, SPC, and using Minitab
- 3D modeling experience.
- Working knowledge of biocompatible metal and/or polymer materials.
- Demonstrate a working knowledge of the required activities and deliverables from each of the development phases.
- Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.