Principal Equipment Design Engineer

What you'll do

• Lead the mechanical design and development of custom machines, automation systems, tooling, and fixtures for medical device production.
• Create and maintain accurate 3D CAD models, assemblies, drawings, and bills of materials using SolidWorks.
• Support equipment qualification and validation activities including IQ/OQ/PQ protocols and test plans.
• Perform engineering analyses such as tolerance stack-ups, failure analysis, root cause investigations, and DFM assessments.
• Lead design reviews focusing on robustness, manufacturability, risk mitigation, and readiness for release.
• Manage project scope, schedules, technical deliverables, and stakeholder communication from concept through release.
• Support equipment FAT, SAT, commissioning, troubleshooting, and post-installation performance investigations.
• Mentor engineers in design controls, documentation discipline, and cross-functional execution.

What we're looking for

• A Baccalaureate degree with 7 years experience, a Master's with 5 years, or a PhD with 3 years is required.
• Significant experience in machine design, automation, manufacturing equipment, or capital equipment development is required.
• Advanced SolidWorks proficiency for complex assemblies and detailed mechanical drawings is required.
• Experience developing accurate engineering documentation in regulated or high-quality environments is required.
• A degree in Mechanical Engineering or a related field is preferred.
• Knowledge of GD&T, tolerance analysis, material selection, and manufacturing processes is preferred.
• Experience with automation systems, robotics, motion control, pneumatics, vision systems, or mechatronics is preferred.
• Bachelor’s degree in Mechanical Engineering or related engineering discipline.