The role will offer you the opportunity to support and lead on projects as a part of the development of Endomag’s future implantable products. As a part of our multi-disciplinary team your technical knowledge and creativity to offer innovative solutions will lead to product demonstrating real clinical benefit for patients and clinical users.
Our cutting-edge medical device products are developed and manufactured in collaboration with a network of third-party suppliers, contract development organisations, and consultants who work alongside Endomag’s R&D team.
You will contribute to multiple projects and coordinate with the other members of the R&D team and wider groups at Endomag.
Endomag is certified to ISO 13485 and product development activities will need to be operated and documented to relevant medical device standards.
Key responsibilities and duties:
- Manage and support the engineering design and development of new medical device products at various stages of development;
- Generate concepts and detailed design considering design for manufacturing; design for high reliability based on engineering analysis; design of experiments;
- Develop and document design requirements; lead design reviews and compile Design History and Technical Files that comply with Endomag’s ISO13485 Quality Management System;
- Manage risks and document risk management according to ISO14971 using techniques such as Hazards identification, risk analysis and evaluation, and design and process FMEA;
- Develop and execute verification and validation test procedures, and test reports;
- Work in a team environment; peer review work;
Qualifications
- Engineering, science or related subject degree or similar discipline
Experience
- 3-5 years in medical device development ideally within implantable devices.
- Experience in aspects of concept generation; engineering analysis and detail design; and formal testing as a part of new product development.
- Experience in writing technical documentation as a part of regulatory submissions such as Technical File or DHF.
- Experience in the management of external design consultants, suppliers and subcontractors.
Desirable Experience
- Experience with CAD would be beneficial.
- Knowledge of manufacturing techniques ideally with experience of transfer to manufacture.
- Understanding of global medical device regulations, requirements, and standards.
Abilities and Skills
- Proven project management, organisational and time management skills.
- Excellent written and presentation skills communicating technical requirements, issues and solutions.
- Well-organised with the ability to work with critical attention to detail and high levels of accuracy.
- Self-motivated and able to manage own workload.
Other
- Willingness to occasionally travel within the UK and Internationally.