Principal Manufacturing Engineer – Laser & Ultrasonic Welding

Planet Pharma; San Diego (CA); On-site; USD 117,000 - 145,000; Full time

Job summary

Planet Pharma is seeking a Technical Specialist with laser and ultrasonic welding expertise to lead design, validation, and optimization across medical device manufacturing lines.

You will define CPPs, lead IQ/OQ/PQ activities, and drive continuous improvement in yield and cycle time while ensuring FDA/ISO compliance and robust process controls.

Qualifications

• Laser welding expert for design, development, and validation.
• Define laser welding specs, CPPs and outputs with R&D, Quality, regulatory.
• Lead IQ/OQ/PQ qualification and validation per FDA/ISO.
• Develop laser weld validation studies including strength, hermeticity testing.
• Drive improvements to optimize weld yield, cycle time and capability.
• Evaluate new laser tech to enhance manufacturing capability.
• Troubleshoot laser welding failures and implement corrective actions.
• Establish laser welding controls and SPC programs.

Responsibilities

• Design manufacturing processes, procedures and layouts for welding operations.
• Arrange machines within facilities for efficient production.
• Define sequence of operations and tooling specs affecting performance.
• Adapt machine design to factory conditions.
• Incorporate inspection and test requirements into the plan.
• Inspect performance of machinery and initiate corrective actions.
• Develop SPC-based manufacturing processes.
• Guide engineering on design concepts and specifications.
• Ensure processes comply with regulations.

Skills

Laser welding

Ultrasonic welding

Process optimization

FDA/ISO compliance

CPPs and process controls

Tools

Coherent

IPG Photonics

TRUMPF

Branson

Evosys

AutoCAD

SolidWorks

SAP

Microsoft Office

Minitab

Document Management Systems

MES

Job description

Pay 85-105/h depending on 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 w/welding equipment


• Microsoft Office, Minitab, Document Management Systems, MES, AutoCAD, SolidWorks, SAP

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 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.

DIFFERENTIATING FACTORS

Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.

Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.

Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems

Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.

Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader

Required Knowledge and Experience:
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 minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.