Responsibilities
- Support the engineering design and development of drug delivery devices at various stages of development, from research, through verification and validation, and into life-cycle management.
- Work with suppliers to ensure that their Engineering output meets engineering best-practise and the requirements of QMS.
- Lead or support technical design reviews to assess for quality, robustness and safety.
- Develop mechanical designs and technical solutions, CAD models and detailed 2D drawings with full GD&T.
- Develop clear and comprehensive product requirements, specifications and verification documentation.
- Ensure compliance with Quality Management System.
- Travel globally as required to support the projects, up to 10% of time out of the office. Travel might include visiting suppliers’ facilities or manufacturing sites.
- Graduate in Engineering, Scientific or other Technical discipline.
- At least 5 years relevant industry experience in product development, from concept to commercialisation.
- Previous experience in the design, manufacture and life-cycle management of medical device or combination products (preferred, or significant specialist expertise from another relevant industry).
- Training in Design Controls, medical device risk management and European Medical Device Directive/Regulations (preferred).
- Experience of design for medical device development, manufacturing or assembly processes (preferred).
- Experience of medical device regulatory requirements for global release (preferred).
- Knowledge of Solidworks 3D CAD (preferred).
Senior Mechanical Engineer Recruitment Agency in London, Engineering Recruitment Agency in London