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.
Skills & Experience Required
  • 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).