Principal Manufacturing Engineer

Responsibilities

• Lead development and execution of manufacturing, test, and validation strategies
• Serve as a technical authority for manufacturing process development and validation of electromechanical products
• Develop and maintain Master Validation Plans (MVPs) covering equipment, processes, software, and test methods
• Lead test method validation (TMV) activities including Gage R&R and robustness studies
• Apply statistical methods such as DOE, Cp/Cpk, and MSA to process characterization
• Author and review technical documentation including validation plans, reports, protocols, and risk assessments
• Provide technical leadership to suppliers and contract manufacturers
• Support new product introduction (NPI), design transfer, and sustaining engineering activities
• Mentor manufacturing and validation engineers

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
• 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
• Strong technical writing and documentation skills

Preferred Qualifications

• Medical device experience (ISO 13485, ISO 14971)
• Experience with SolidWorks and Minitab
• Familiarity with schematic tools like OrCAD
• Experience with single-use device processes (adhesive bonding, thermal welding, injection molding, extrusion)