Process Design and Development Engineer
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About The Position
As Principal Engineer, Early Process Design and Development in Lake Forest, CA, the ideal candidate will be a senior member of a high-performing team, specialized in the design and development of processes, fixtures, and test methods used in new product development. In this role, you will be expected to embed as the Process Design and Development representative on R&D project teams responsible for estimating budgets and timelines for all process design and development activities on a project. You will manage and prioritize multiple projects in a dynamic fast-paced R&D environment and be self-accountable to ensure all project goals and objectives are completed per committed timelines. You will work well with and collaborate with cross-functional teams, providing technical expertise on a project and supporting both internal and external manufacturing sites as well as third-party manufacturers. Communication and presentation of project status and risks to leadership and project leads will be crucial to ensure adequate support is provided, as well as timely escalation of issues to ensure project success. Collaborating with product design teams to ensure manufacturability of new designs is accounted for will be essential to ensure a smooth transition from development to production. Your responsibilities will include planning, organizing, scheduling, and managing process design and development activities on projects to ensure concurrent engineering of new processes and technologies. You will research, develop, and introduce new technologies for use in the fabrication and testing of innovative product designs, evaluate new products for manual and automated assembly, and design and fabricate prototype equipment and fixtures. Additionally, you will investigate and integrate leading-edge automation technology into new products as appropriate, create CAD files and pertinent documents for implementation of manual, semi-automated, and automated component fabrication and electro-mechanical assembly and final testing, and supply knowledge and facilitate execution of process validation activities and documentation such as IQ/OQ/PQ. You will lead bench testing method creation for new processes and technology, retrofit existing processes and equipment with updated capabilities and technology, and work with design engineers and/or vendors to develop solutions to complex problems by designing processes, tools/fixtures that can work with various fabrication and assembly processes and equipment. Evaluating component, subassembly, and/or assembly supplier capabilities and technologies for use in the development of new products will also be part of your role. You will coordinate and oversee builds at suppliers and evaluate for design, regulatory, and business requirements. Utilizing Six Sigma methodologies such as DMAIC or DFSS to characterize and optimize new process designs, develop performance criteria, equipment, and/or test fixtures will be expected, along with utilizing risk management tools such as Fault Tree Analysis and Failure Mode and Effects Analysis to understand and quantify risks and understand design or process trade-offs. You will create and maintain a Process Flow Diagram for manufacturing and assembly of electro-mechanical medical devices, maintain initial standard operating procedures and test methods for Design Verification testing and/or manufacturing processes, coordinate R&D Pilot Line builds, and support manufacturing builds as part of transfer activities. Finally, you will provide coaching, mentoring, and training of team or less experienced engineers to build and strengthen the culture of the organization.
