The Development Engineer plans, coordinates, and manages the activities associated with Product Development projects to ensure compliance with requirements during development of the client's Medical Device products, or lifecycle management of existing products.
Main duties and responsibilities:
Assure that all applicable elements and product technical standards are effectively incorporated into new designs and into changes to designs.
Contribute to design input requirements from experience with previously reported problems from internal sources (non-conforming material reports, yield, rework) or external sources (customer complaints), competitive devices and/or other similar products.
Writing and updating design control documentation to ensure design traceability.
Lead design reviews through the design process.
Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested.
Lead and/or support Risk Management activities, for new and/or modified products which includes ensuring that risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
Support quality team on process validation to ensure successful design transfer into manufacturing.
Responsible for design verification planning and reporting.
Support on biocompatibility assessment for new products or changes in design.
Lead design change activities for CE marked products, supporting product lifecycle and post market surveillance activities.
Involvement in internal audits, external audits and risk assessments for design and development aspects, taking corrective actions where necessary.
For immediate consideration please forward your most up to date CV.