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Integra LifeSciences is currently recruiting for a Sr. Manufacturing Engineer located in Irvine, CA.
This position is responsible to execute and manage project assignments in the evaluation, selection, and application of various engineering techniques, procedures, and criteria with minimal supervision. Independently plans, schedules, and leads detailed phases of the engineering work in a part of a major project or in a total project of moderate scope. Solves basic and complex problems identified through process characterization, monitoring and trending. This position is expected to consider and execute innovative approaches in the development of new processes, equipment and systems. The incumbent should be able to complete complex design and engineering tasks and manage projects with little assistance. This includes constructing detailed, accurate project schedules, interfacing with internal and external engineering & technical resources in solving project problems, and having the ability to prioritize multiple projects and tasks.
Primary responsibilities include the following:
· Responsible for Manufacturing Engineering and Project Management to support the optimization of existing processes and the introduction of new products and processes, either through PD Transfers or transfers of existing manufacturing processes. Projects assigned are typically higher level capital projects with increased complexity, and can pose significant risk to product and processes if not designed and implemented correctly
· Responsible for manufacturing and process engineering, the extent of which includes execution of IQ/OQ/PQ/PV validations, packaging design and validation, equipment and tooling design, and manufacturing process troubleshooting. Must be able to manage multiple projects in their entirety, and be able to perform / deliver necessary project tasks as directed.
· Perform timely technical investigations and provide practical manufacturing solutions, under all appropriate regulatory guidelines applicable to the Medical Device Manufacturing Industry. This includes the effective implementation and utilization of problem solving skills and techniques to identify root causes, corrective and preventative actions, assess results and develop and implement mitigation and resolution plans and activities.
· Provide daily analytical and technical support to meet manufacturing objectives
· Assemble and lead technical teams for identified projects and products, which may include personnel from Engineering, Manufacturing, Product Development, Marketing, QA, and Clinical & Regulatory Affairs
· Lead teams in performing and updating Process FMECA risk management
· Coordinate specific efforts of the project team, including the core team members (Manufacturing, Plant QA/QC/RA, Facilities, Materials Management, and Engineering) and supporting members (Corporate Regulatory, Finance, etc.).
· Ensure that all appropriate documentation, drawings specifications are generated in compliance with Integra’s procedures and statutory requirements ( US FDA and ISO)
· Completes assigned projects following ISO and GMP’s, in a timely matter.
· Develops and maintains engineering drawings as required.
· Develops standard operating procedures (SOP’s) to support validation and process improvement projects.
· Writes and completes validation protocols (IQ/OQ/PQ).
· Maintains BOM’s and routings to ensure accuracy.
· Performs any other related duties as required.