Principal Manufacturing Engineer

The Principal Manufacturing Engineer is a hands-on technical leader responsible for new product introduction and for defining, validating, and sustaining robust manufacturing processes for electromechanical medical devices.

Requirements

• Bachelor’s degree in Mechanical, Electrical, Manufacturing, Biomedical Engineering, or related field
• Minimum of 10 years of manufacturing engineering experience in a regulated environment
• Medical device experience preferred (ISO 13485, ISO 14971)
• Expertise in electromechanical manufacturing processes (PCB assembly, cable/harnessing, machining, sheet metal)
• Strong statistical analysis and validation experience
• Knowledge of regulatory requirements for medical devices
• Experience with SolidWorks and Minitab preferred
• Familiarity with schematic tools (e.g., OrCAD) is a plus
• Experience with single-use device processes is desirable
• Strong technical writing and documentation skills
• Ability to manage projects and work cross-functionally

Benefits

• Comprehensive benefits package