Principal Manufacturing Engineer - Laser & Ultrasonic Welding

Responsibilities may include the following and other duties may be assigned:
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 the 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. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

Ensures processes and procedures are in compliance with regulations.

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies –from design to implementation - while adhering to policies, using specialized knowledge and skills.

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. §214.2(h)(4)(iii)(A)) and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.

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.

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…