Staff Mechanical Design Engineer

Staff-level mechanical design engineer position focused on developing high-volume manufacturing automation equipment for medical device assembly. The role spans concept through production release, including in-house equipment design, OEM supplier evaluation, and technical project leadership within a regulated environment.

Responsibilities

• Design and develop in-house manufacturing equipment and automation systems from concept through production release
• Create detailed equipment specifications, 3D models, engineering drawings, and tolerance analyses for internal and external systems
• Evaluate OEM suppliers, define technical specifications, and oversee design and qualification activities
• Lead equipment design reviews, risk assessments, and troubleshooting; manage projects through design control and qualification processes
• Develop testing strategies and acceptance criteria; mentor engineers and provide production support for continuous improvement

Requirements

• BS or MS in Mechanical Engineering or related discipline
• Minimum eight years designing manufacturing equipment or automation systems
• Direct experience in medical device manufacturing environments
• Proficiency with 3D CAD and GD&T; SolidWorks preferred
• Demonstrated ability integrating mechatronic components and managing OEM relationships
• Experience with equipment qualification, process validation, and regulated quality systems
• Staff-level candidates must show technical depth and leadership of complex projects