Job Description
About the Role We 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 Do Design, model, and prototype automated assembly and test equipment using SolidWorks Lead automation projects from concept through floor implementation Serve as the primary technical contact for external automation vendors Define URS requirements and lead FAT/SAT activities Author and execute IQ/OQ/PQ validation protocols Provide expert troubleshooting and sustaining support for automated lines Drive continuous improvement using Lean and Six Sigma principles Partner cross‑functionally with R&D, Operations, and Quality to support DFM and production scale‑up What You Bring Bachelor’s degree in Mechanical Engineering, Mechatronics, or related field 5–8+ years of mechanical design experience 3+ years focused on medical device automation Advanced 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 production Strong understanding of ISO 13485 and FDA 21 CFR Part 820 Why This Role Matters You’ll directly impact manufacturing scalability and efficiency You’ll lead automation decisions in a regulated, high‑precision environment You’ll reduce reliance on external integrators by owning automation internally You’ll balance hands‑on engineering with technical leadership Who Thrives Here Engineers who are equally comfortable designing in CAD and working on the shop floor Professionals who value precision, accountability, and ownership Leaders who can manage vendors, timelines, and technical risk