Mechanical Engineer

Own mechanical architecture and subsystem integration including enclosures, mechanisms, mounts, thermal paths, cable routing, and EMI/EMC considerations. Translate system requirements, user needs, and electrical/software constraints into robust mechanical designs. Develop and review 3D CAD models, engineering drawings, GD&T, and BOMs. Integrate motors, sensors, PCBs, batteries, power supplies, connectors, and cabling into mechanical assemblies. Ensure compliance with FDA regulations, ISO 13485, ISO 14971, and applicable IEC standards. Maintain Design History File (DHF) documentation. Lead risk management activities including DFMEA, PFMEA, and hazard analysis. Support engineering change management through ECO and ECN processes. Define verification strategies and support EVT, DVT, and V&V testing activities. Investigate design, testing, manufacturing, and field failures and implement corrective actions. Apply DFM/DFA principles to optimize manufacturing readiness. Collaborate with suppliers and contract manufacturers on tooling, materials, processes, and yield improvements. Support FAI, PPAP, pilot builds, and manufacturing transfer activities. Resolve NCRs, deviations, and manufacturing issues related to mechanical design. Work closely with electrical, software, systems, quality, regulatory, and supply chain teams. Participate in design reviews, technical discussions, and customer meetings. Perform engineering analyses including tolerance stack-ups and FEA. Support cost reduction, design optimization, and next‑generation product development initiatives. Mentor and guide junior engineers. Required Qualifications Bachelor's degree in Mechanical Engineering or related discipline. 8–12 years of mechanical product development experience. Significant experience developing medical devices in regulated environments. Strong experience with electromechanical systems integration. Expertise in CAD modeling, GD&T, tolerance analysis, and mechanical design. Knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC standards. Experience with DFMEA, PFMEA, risk management, DFM/DFA, and manufacturing transfer. Proven success leading products through the full development lifecycle from concept through production release. #J-18808-Ljbffr