Responsible to: Group R&D Manager
Purpose of Job (Summary)
Summary of Role:
Deliver engineering and design solutions (technical judgement/practical skill and experience) in new product design, product improvements and manufacturing new-process improvements. To use technical knowledge and expertise in the design and development of product line extensions and innovative products in healthcare (body aesthetics: augmentation and reconstruction procedures).
Responsible for the design, research and development of allocated product projects in accordance with Design & Development Control procedures in accordance with ISO13485 and company Quality Management System (QMS) and meeting the agreed project timelines, milestones and budget.
Complete allocated new equipment, software and process validation tasks on time in accordance with ISO13485 and company Quality Management System (QMS) and to the appropriate standard(s) as applicable and as required for new product introduction activities.
Generate and compile technical documentation, design history files and manufacturing work instructions for all changes to product designs or new-processes.
Plan, organise and coordinate design/development and new-process work within assigned projects.
Liaise with production during design-for-manufacture and transfer to production of new or modified product ranges.
Generation of concepts, designs and prototypes which address given product requirements.
Ensure the successful transfer of products and new process changes into manufacturing.
Source external services and suppliers as required meeting design/development project needs.
Lead a project(s) as appropriate. The project leading role will require the job holder to undertake the following: –
- To take general assigned project objectives and generate a detailed project plan and schedule with the project team.
- Maintain and revise project schedule & plan by gaining commitment from project team, and line managers.
- Coordinate and direct activities initiated within the project as per internal design control procedures and ISO standards as appropriate.
- Ensure timely and appropriate written and verbal communication of project progress.
- By gaining the commitment of the project team, line managers and commercial team ensure that agreed project timescales and milestones are met.
Compiling and presenting project updates to R&D Manager, project teams and executive management when required.
Maintain and develop an in-depth knowledge of own area by appropriate reading, literature work and authorised attendance at courses, workshops, conferences, and surgeries.
Apply expertise to improving the quality of the design input into GCA company projects, new-processes existing processes (where applicable) and to identify opportunities for the company.
Qualifications Required / Desired:
Degree qualified (2.2 Honours minimum) in either one or more of the following disciplines: Mechanical Engineering, Electrical Engineering, Design Engineering, and/or Bioengineering,
Experience in product and new process development and gained within the medical device industry.
Experience of leading product development and new process projects involving multi-disciplinary teams.
Experience of new product introduct introduction in mediacal devices industry
Knowledge of quality management systems (ISO 13485, 21 CFR 820 and or ISO 90001)
Experience with Design Control procedures
Good communication, interpersonal, and presentation skills
Effective computing (including Microsoft Project), literacy and numeracy skills.
Working knowledge of MDD 93/42/EEC, MDR, Good Laboratory Practice (GLP) and or Current Good Manufacturing Processes (cGMP)
Knowledge of regulatory requirements for the approval of medical products with regard to development and production.