Senior Manufacturing Automation Engineer
About the RoleWe are seeking a Senior Manufacturing Automation Engineer to serve as the technical leader for our manufacturing automation and scaling initiatives. This role owns the end-to-end lifecycle of automated production systems , from designing custom internal fixtures to leading large-scale outsourced automation projects with external integrators.This position plays a critical role in increasing throughput, improving precision, and ensuring all automation meets medical device quality and regulatory standards , while supporting sustained production performance.What You'll DoDesign, model, and prototype automated assembly and test equipment using SolidWorksLead automation projects from concept through floor implementationServe as the primary technical contact for external automation vendorsDefine URS requirements and lead FAT/SAT activitiesAuthor and execute IQ/OQ/PQ validation protocolsProvide expert troubleshooting and sustaining support for automated linesDrive continuous improvement using Lean and Six Sigma principlesPartner cross-functionally with R&D, Operations, and Quality to support DFM and production scale-upWhat You BringBachelor's degree in Mechanical Engineering, Mechatronics, or related field5-8+ years of mechanical design experience3+ years focused on medical device automationAdvanced SolidWorks proficiency (CSWP preferred)Experience with robotics, high-speed automation, and vision systems (Fanuc, Epson, Cognex, Keyence)Proven success leading $500k+ automation projects from RFQ to productionStrong understanding of ISO 13485 and FDA 21 CFR Part 820Why This Role MattersYou'll directly impact manufacturing scalability and efficiencyYou'll lead automation decisions in a regulated, high-precision environmentYou'll reduce reliance on external integrators by owning automation internallyYou'll balance hands-on engineering with technical leadershipWho Thrives HereEngineers who are equally comfortable designing in CAD and working on the shop floorProfessionals who value precision, accountability, and ownershipLeaders who can manage vendors, timelines, and technical risk