Staff Mechanical Engineer - Equipment
Core
Design and develop high-volume automation manufacturing equipment and tooling for medical device production, managing the full lifecycle from concept to production release.
Role type
Staff Mechanical Engineer (Equipment & Automation)
Builds
In-house proprietary manufacturing equipment, automation systems, and tooling for medical device assembly.
Domain
Medical device manufacturing / High-volume automation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design fundamentals, GD&T, tolerance analysis, 3D CAD (SolidWorks), mechatronics integration (robotics, sensors, pneumatics), equipment qualification, statistical quality tools (Cpk, Gauge R&R), supplier evaluation, technical documentation, project execution, mentorship
Preferred skills
ISO 13485 regulated environment experience, high-volume medical device assembly, turnkey automation management, Windchill/Agile PLM, design controls and risk management
Technologies
SolidWorks, 3D CAD, robotics, sensors, pneumatics, motion control, machine vision, Windchill
Responsibilities
Design and develop manufacturing equipment from concept to production release; translate process needs into equipment specifications; integrate mechanical designs with mechatronic components; evaluate and select OEMs and system integrators; lead design reviews, risk assessments, and troubleshooting; develop testing strategies and qualification protocols; provide technical support for production operations and continuous improvement; mentor engineers and technicians
Seniority
Staff, hands-on IC with strategic leadership