Due to continued expansion of their operations our client a well-established Multinational Medical Devices manufacturer now require a qualified and experienced Manufacturing Process Engineer.
Drive a team of Engineers focused on identification, development, and implementation of new processes required for the manufacture of device designs.
Manage the development implementation and validation of all processes.
· Generate Process and Test method validation protocols and reports. Ensure that process validations and work methods are adequate to maintain the highest quality standards
Where appropriate apply Lean Manufacturing principles to the design and implementation of new processes.
Work with the Engineering, R&D and other Senior Engineers to ensure the appropriate allocation of resources and prioritisation of efforts for the overall goals.
Build strong and effective relationships with other business units.
Assist with supplier selection, process development and validation.
Support Regulatory Affairs as required with engineering input for process related submissions and renewals prior to and post initial release of devices to market.
Ensure the effective transfer of products between entities.
Provide engineering input and support to those responsible for Supplier instigated changes.
Ensure the effective transfer of new devices.
Responsible for process engineering layout plans and implementation in relation to new processes and production lines.
Investigation and resolution of Non Conformances associated with devices post release to market.
Support the post market surveillance of devices in terms of complaint investigation and risk analysis.
Drive the compliance culture amongst Manufacturing Engineering team members and ensure that compliance requirements are always met.
Liaise with other manufacturing facilities and the sharing of best practice processes.
Support other cross functional groups to achieve company goals.
Benchmark systems and processes against best industry practice, modify and develop accordingly to further improve operational efficiencies.
Relevant 3rd Level Engineering qualification
6 years + experience in the area of Manufacturing, New Product Introductions or Process Engineering within Medical Devices Sector
Able to demonstrate knowledge in the manufacturing, process development and validation of new products is highly desired
Strong proven people management skills. Previous experience in a supervisory position desired.
Proven project management capabilities.
First class interpersonal skills and the ability to communicate at all levels of the organisation.
Excellent knowledge of medical device quality standards ISO13485/FDA practices and GMP or similar regulated industry standards.