Project Manager/Engineer
Huntleigh Healthcare Ltd
•Medical devices project management and product classification requirements covered by directive 93/42/EEC•Design, development and full product industrialisation from within an R&D environment, prototype manufacturing, testing and analysing, involving bio-compatibility, functional safety, mechanical/electrical safety, environmental, EMC and clinical performance, managing risk assessment teams•Design of experiments •Defining validation programs and pass criteria•Liaising with regulatory bodies, MHRA & FDA•Liaising with authorised bodies BS/ISO and UL/TUV, independent test houses and patents office•Developing and managing multi-disciplined project teams including managing CAD department and laboratory technicians •Responsible for managing Huntleigh’s change control system and database based on Prince 2 protocols with phase gates and stage boundaries, concept, design and development, launch product acceptance and close-out•Developing and maintain design history, regulatory and technical files within the framework of international standards 21 CFR part 820, ISO9001and ISO13485 •Attending, chairing and reporting on scheduled meetings/project meetings etc. implement •Identification and procurement of new materials, machines and suppliers•Compliance marking for medical devices•Working with international standards committees to prepare framework for anti-decubitus support surfaces and wheelchair seating testing protocols•Identifying and developing new suppliers