Principal Manufacturing Engineer - Laser & Ultrasonic Welding

Lancesoft; San Diego (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

LanceSoft in San Diego, CA seeks a senior technical specialist focused on laser and ultrasonic welding for medical devices. You will design, validate, and optimize welding processes across manufacturing lines, collaborating with R&D, Quality, and Regulatory teams.

Responsibilities include defining process specs, leading IQ/OQ/PQ studies, and driving improvements in yield and cycle time while ensuring FDA/ISO compliance. Strong problem-solving and cross-functional leadership are essential.

Qualifications

• Requires Bachelor's degree and 7+ years of relevant experience, or an advanced degree with 5+ years.
• Expertise in laser and ultrasonic welding processes for medical device manufacturing.

Responsibilities

• Define laser welding process specifications, acceptance criteria, and CPPs.
• Lead qualification and validation activities (IQ/OQ/PQ) per FDA/ISO.
• Drive continuous improvement to optimize weld yield, cycle time, and process capability.
• Troubleshoot and resolve complex welding failures with root-cause analysis.
• Establish and maintain welding process controls and SPC programs.

Skills

Office software proficiency

Minitab

Document Management Systems

MES

AutoCAD

SolidWorks

SAP

Troubleshooting

Cross-functional collaboration

Education

Bachelor's degree

Tools

Laser welding equipment (CO2/Nd:YAG/fiber)

Welding modalities

IQ/OQ/PQ

FDA/ISO compliance

Job description

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.

Technical Specialist Career Stream

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.

Job Requirements

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.

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.

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. Experience with alternative plastic joining technologies (e.G., laser welding, heat staking, vibration welding) for comparative process selection, hermetic sealing validation, weld inspection, horn and fixture design, and acoustic stack optimization. Experience supporting Contract Manufacturers in a medical device environment. Familiarity with MES (Manufacturing Execution Systems) integration with welding equipment. Proficiency in Microsoft Office, Minitab, Document Management Systems, MES, AutoCAD, SolidWorks, SAP.

Location

Join us in beautiful San Diego, CA, where innovation meets lifestyle. Enjoy the perfect blend of work and leisure in a city renowned for its vibrant culture, stunning beaches, and thriving tech industry.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.