Staff Mechanical Engineer - Equipment

Primary Function

Essential Job Duties

• Design manufacturing equipment, automation systems, tooling, and fixtures from concept through production release.
• Translate manufacturing needs into equipment requirements, specifications, and acceptance criteria.
• Create 3D models, engineering drawings, tolerance analyses, bills of material, and technical documentation.
• Integrate mechanical designs with robotics, sensors, motors, pneumatics, motion control, machine vision, and safety systems.
• Evaluate OEMs and system integrators and oversee externally sourced equipment through qualification.
• Lead design reviews, risk assessments, troubleshooting, and technical problem-solving.
• Guide projects through design control, engineering change, qualification, and release processes.
• Develop equipment testing, acceptance, qualification, maintenance, and calibration plans.
• Apply Cpk, Gauge R&R, tolerance analysis, and quality tools to improve capability and reliability.
• Support production, continuous improvement, capacity expansion, and equipment lifecycle management.
• Mentor engineers, technicians, and cross-functional project team members.

Required Skills and Experience

• Experience with high-volume automation lines and hands-on manufacturing environments.
• Experience designing and releasing manufacturing equipment or complex automated systems into production.
• Proficiency in 3D CAD and engineering drawing development; SolidWorks experience is preferred.
• Strong mechanical design, mechanism development, GD&T, tolerance analysis, material selection, and manufacturing process knowledge.
• Ability to integrate mechatronic components including robotics, sensors, motors, pneumatics, motion control, and machine vision.
• Experience specifying automation equipment and reviewing supplier designs, drawings, components, and acceptance plans.
• Experience with equipment qualification, process validation, and regulated quality systems.
• Strong analytical, troubleshooting, project execution, documentation, written communication, and verbal communication skills.
• Self-motivated, able to take initiative, and effective in multidisciplinary teams.

Education and Training

• Bachelor’s or Master’s degree in Mechanical Engineering or a related engineering discipline.
• At least eight years of relevant experience developing manufacturing equipment or automation systems.
• Direct medical device manufacturing experience is required.
• Staff-level consideration requires additional technical depth and leadership of complex equipment or automation projects.

Preferred Experience

• ISO 13485-regulated medical device manufacturing experience.
• Experience designing equipment for high-volume assembly of medical devices or precision products.
• Experience managing internally designed equipment and externally sourced turnkey automation systems.
• Experience with OEM selection, technical bid evaluation, design reviews, factory acceptance testing, site acceptance testing, and production qualification.
• Familiarity with design controls, risk management, engineering change control, and equipment validation.
• Windchill and Agile product lifecycle management experience is a strong plus.
• Experience mentoring engineers or establishing equipment design standards and best practices.

About Intuitive