Process Design and Development
Overview
As Principal Engineer in Early Process Design and Development, you will lead the creation and validation of fabrication processes, tools, and test methods for new ophthalmic surgical equipment. You’ll partner with R&D and product design to ensure manufacturability and smooth transfer to production, while guiding projects across budgets and timelines. Your role drives technology adoption, automation, and robust process validation in a fast-paced environment. This is a hands-on, cross-functional leadership position with a strong impact on product success.
ResponsibilitiesEmbed as Process Design and Development representative on R&D teams to estimate budgets and timelinesManage and prioritize multiple projects in a fast-paced R&D environmentCollaborate with cross-functional teams and external manufacturing sitesPlan, organize, schedule, and manage process design activities for concurrent engineeringResearch and introduce new fabrication/automation technologiesDesign and fabricate prototype equipment and fixturesLead process validation activities (IQ/OQ/PQ)Develop and maintain process flow diagrams and SOPsCoordinate R&D pilot line builds and transfer activitiesCoach and mentor engineers to strengthen the organization culture
Key requirementsExperience in design and development of processes, fixtures, and test methodsExcellent project management and cross-functional leadershipStrong analytical, problem-solving, and decision-making capabilitiesProficiency with Creo Parametric (ISDX, Simulate, Pro-Process, Sheet Metal, Mechanism)SolidWorks is a plusExperience with GD&T and tolerance analysisKnowledge of DFM, DFA, DFTSix Sigma methodologies (DMAIC/DFSS) and risk assessment tools (FTA/FMEA)Experience with IQ/OQ/PQ and Gage R&RExperience programming PLCs and GUIs (e.g., Ladder Logic, LabView)Effective communicator across all levelsConflict resolutionMentorship and coachingCreo Parametric proficiencySolidWorks (plus)3D CAD for plastics/die cast/sheet metal/machining