Lead Manufacturing Process Engineer – AME & Testing

Role Overview

Roles and Responsibilities

• Lead NPI, manufacturing transfer, process engineering, manufacturing readiness, production ramp-up, and new testing technology activities.
• Design, develop, improve, and support automation systems, test equipment, SPMs, fixtures, tooling, and manufacturing aids.
• Develop and support automated equipment involving motors, encoders, sensors, electrical circuits, machine controls, and NI hardware programming.
• Lead troubleshooting, root cause investigations, failure analysis, process qualification, validation, risk assessments, and quality improvements.
• Use Power BI, equipment data, AI/ML, IoT, and advanced analytics to improve testing, productivity, quality, and predictive maintenance.
• Manage engineering changes, QMS implementation, technical documentation, validation records, specifications, and work instructions.
• Provide technical leadership and coaching to engineers, contractors, and graduate trainees while managing multiple engineering priorities.

Required Qualifications

• Bachelor’s or Master’s degree in a listed engineering discipline or a related engineering field.
• Minimum 6+ years of relevant process, manufacturing, test, automation, or advanced manufacturing engineering experience.
• Hands-on experience with manufacturing process development, equipment development, test automation, SPMs, electromechanical systems, and equipment controls.
• Strong troubleshooting, root cause analysis, failure analysis, structured problem-solving, Lean Manufacturing, Six Sigma, and data analysis capabilities.
• Knowledge of qualification, validation, QMS requirements, Power BI or similar tools, and digital manufacturing technologies.
• Experience providing technical guidance or supporting at least two team members, contractors, or trainees.

Desired Characteristics

• Strong written and verbal communication across engineering, manufacturing, quality, supply chain, and other cross-functional teams.
• Experience in medical device or medical equipment manufacturing and complex electromechanical products.
• Experience with NPI, industrialization, manufacturing transfer, production ramp-up, equipment upgrades, or legacy testing transitions.
• Knowledge of PCB and electronics manufacturing, testing, Power BI applications, AI/ML, IoT, predictive maintenance, and manufacturing analytics.
• Experience with process risk assessments, DPU reduction, reliability improvements, and mentoring technical personnel.

Workplace

• The source includes an onsite work designation.