Principal Manufacturing Engineer

ATR International; San Diego (CA); On-site; USD 130,000 - 185,000; Full time

Job summary

ATR International in San Diego seeks a contract Manufacturing Specialist focused on laser and ultrasonic welding for medical device manufacturing. You will design processes, validate welds, and drive process improvements across lines, collaborating with R&D, QA, and Regulatory teams.

The role emphasizes advanced welding technologies, CPPs, IQ/OQ/PQ, and continuous improvement, with a 12+ month contract and pay up to $114 per hour.

Qualifications

• Requires mastery of a specialty area and full knowledge of industry practices.
• Baccalaureate degree or higher with substantial relevant experience.
• Experience with laser and ultrasonic welding in medical device manufacturing.

Responsibilities

• Design manufacturing processes, layouts, and procedures for welding and fabrication.
• Lead laser and ultrasonic welding process validation (IQ/OQ/PQ) and CPPs.
• Drive continuous improvement to optimize weld yield and cycle time.
• Coordinate with R&D, QA, and Regulatory for compliance and optimization.

Skills

Laser welding

Ultrasonic welding

Process design

SPC

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

Minitab

AutoCAD

SolidWorks

MES

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 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.

Job Requirements

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. 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: o 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) o Experience with multiple laser/ultrasonic welding modalities (e.g., Nd:YAG, fiber laser, diode laser, CO2; standard ultrasonic, multi-frequency, continuous ultrasonic welding) o 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 (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 o Experience supporting Contract Manufacturers in a medical device environment o Familiarity with MES (Manufacturing Execution Systems) integration w/welding equipment

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

Job Notes:

• 12+ months contract (extensions/conversions are possible depending on client needs.)
• Pays up to $114/hr
• Valid Passport will be required (you'll be expected to travel to Tijuana, Mexico for a contractor Manufacturing Site 3x a week).