Principal Manufacturing Engineer

Role details

Job Overview

We are seeking a dynamic and experienced Principal Manufacturing Engineer to lead the development, optimization, and innovation of manufacturing processes within our facility. BS Engineer - Biomedical /MS preferred

Principal Manufacturing Engineer - primary subject matter expert for laser welding process design, development, implementation, validation, and optimization across medical device manufacturing lines - Lead the qualification and validation of laser welding equipment and processes (IQ/OQ/PQ) . BS Engineering 8+ years exp

Preferred Qualifications

• Hands-on experience with industry-leading laser/ultrasonic welding systems (e.g., Coherent, IPG Photonics, TRUMPF, Branson, Evosys or equivalent; Branson, Herrmann, Dukane, Rinco, or equivalent)
• Experience with multiple laser/ultrasonic welding modalities (e.g., Nd:YAG, fiber laser, diode laser, CO2; standard ultrasonic, multi-frequency, continuous ultrasonic welding)
• Experience with laser transmission welding (LTW) for thermoplastic components; experience with hermetic sealing validation and leak testing methodologies o Experience with alternative plastic joining technologies

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.

• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.

• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

• Adapts machine or equipment design to factory and production conditions.

• May incorporate inspection and test requirements into the production plan.

• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

Laser Welding expertise requirements:

• Serve as the primary subject matter expert for laser welding process design, development, implementation, validation, and optimization across medical device manufacturing lines

• Define laser welding process specifications, acceptance criteria, and critical process parameters (CPPs) and process outputs in collaboration with R&D, Quality, and Regulatory teams

• Lead the qualification and validation of laser welding equipment and processes (IQ/OQ/PQ) in compliance with FDA and ISO regulations

• Develop and execute laser weld process validation studies, including weld strength characterization, hermeticity testing, and visual inspection criteria

• Drive continuous improvement initiatives to optimize laser weld yield, cycle time, and process capability

• Evaluate and recommend new laser welding technologies, equipment, and methodologies to enhance manufacturing capability and efficiency

• Troubleshoot and resolve complex laser welding failures, driving root cause analysis and implementing sustainable corrective actions

• Establish and maintain laser welding process controls, monitoring strategies, and SPC programs Ultrasonic Welding expertise requirements:

• Serve as the primary subject matter expert for ultrasonic welding process design, development, implementation, validation, and optimization across medical device manufacturing lines

• Define ultrasonic welding process specifications, acceptance criteria, and critical process parameters (CPPs) and process outputs in collaboration with R&D, Quality, and Regulatory teams

• Lead the qualification and validation of ultrasonic welding equipment and processes (IQ/OQ/PQ) in compliance with FDA and ISO regulations

• Develop and execute ultrasonic weld process validation studies, including weld strength characterization, hermeticity testing, and visual inspection criteria

• Drive continuous improvement initiatives to optimize ultrasonic weld yield, cycle time, and process capability

• Evaluate and recommend new ultrasonic welding technologies, equipment, and methodologies to enhance manufacturing capability and efficiency

• Troubleshoot and resolve complex ultrasonic welding failures, driving root cause analysis and implementing sustainable corrective actions

• Establish and maintain ultrasonic welding process controls, monitoring strategies, and SPC programs

Pay: $90.00 - $110.00 per hour

Work Location: In person