Production/Manufacturing Engineer

Production/Manufacturing Engineer
Salary Guide: To c£35,000 (Negotiable) + Package & Benefits
Location: Surrey

The purpose of this role is to lead, direct and manage the planning and execution of all design transfer to manufacturing activities on I&D Healthcare projects. Accountable for all activities related to the manufacture of new products including the generation of production documentation, controlling and monitoring the supplier/manufacturer, process risk analysis, process validation etc.

Key Responsibilities include:
Design Development / Design Transfer.
To provide valuable input in the design phases of a project on all aspects of manufacturability (materials selection, manufacturing techniques, tolerances etc.) to ensure these are incorporated into the design at an early stage.
To develop the appropriate documentation to support the regulatory approvals process whether by European (CE) or US (510k/PMA) routes. In alignment with the existing Quality Management System.
To act as liaison with a 3rd party manufacturer to ensure design transfer occurs efficiently.
To ensure that the design of new products is such that we are able to manufacture them in a cost efficient, timely manner.
To be the internal manufacturing/production expert in all aspects and share best practices with the broader team.
To develop processes/procedures for design transfer process and provide training to team members.
To develop detailed design transfer plans to ensure the transfer to manufacture process is smooth and efficient.
To play a key role in the identification and selection of third party manufacturers.

Project Management:
To drive effective and successful delivery of the design transfer process working closely with the Project Manager / Technical Lead.
To carry out project planning for the design transfer process working closely with the Project Manager.
To build strong working relationships with external partners such as suppliers, manufacturers and test houses as appropriate to the project.

Technical Support:
To provide a strong interface between the Technology Development team & the operating divisions, so that new products are successfully brought to market and supported through launch and operation.
To provide manufacturing/production input to the screening of opportunities & the preparation of business cases to obtain the necessary investment approval from management.

Candidates will need to demonstrate:
Technical competence.
Knowledge and experience in the manufacture/production of medical devices.
Experience working in a highly regulated environment under a Quality Management System.
Knowledge of the design and development of medical devices and production techniques.

Impact & Influence:
Excellent communication and organisational skills.
Encourages dialogue to facilitate agreement with others.
Credible in the role and gains personal attention and respect.

Other:
Self starter, capable of working without close supervision.
Comfortable with working in an 'extended' team environment.
Technical / Engineering degree.
Experience in design transfer in international teams.
Experience with production process steps and quality assurance.
Management of external development departments and manufacturers.
A well founded knowledge of material characteristics, bio compatibility and technologies and statistical process control.
A number of years experience in a manufacturing/ production/development environment.
Medical device experience preferred but not essential. (Regulated sector experience ideally)
Experience with electronics manufacture considered a plus.