To provide specific, yet flexible, technical, and project management skills in support of 7x 24 fabrication of medical devices; the design and development, and qualification of new processes/equipment; the scale-up, validation, and commercialization of new products; the continual improvement of existing technologies; and achieving optimal performance of existing operations.
· Provide engineering expertise in support of the scale-up and development of new products and processes. This includes methods, procedures and specifications to ensure a timely and right first time transfer to Manufacturing.
· Provide technical expertise to continual improvement teams, developing process methods, designing/sourcing equipment, conducting feasibility/developmental trials, defining and executing validation requirements, authoring documents/specifications/drawings, and providing on-the-job training to ensure the effective transfer/start-up of new/refined products/processes.
· Manage equipment and process validations, including creation of the protocol, identification of test requirements, analysis and presentation of results, and creation of the final report, in accordance with internal procedures and external regulations.
· Utilize Lean Manufacturing principles and appropriate tools to drive continual improvement of key operational measures, e.g. yield, velocity, takt time, inventory, nonconformances, etc.
· Provide engineering support to all Manufacturing groups to ensure that production requirements are satisfied.
· Prepare presentations and reports, as appropriate, to communicate status of engineering projects, progress towards goals and objectives, future opportunities, and current risks/alternatives to senior management.
Scope of Position: