Technical Lead, Manufacturing Line

ATR International; Los Angeles (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

ATR International seeks an engineering leader to provide technical leadership for production lines, focusing on safe, compliant, efficient, and reliable manufacturing operations. You will lead process validations, equipment reliability, and continuous improvement initiatives while collaborating with Operations, Quality, Regulatory, and other cross-functional teams.

The role tackles NPI support, line readiness, tech transfer, and manufacturing scale-up, ensuring FDA/ISO compliance and driving OEE

Qualifications

• Requires Baccalaureate degree; for non-US degrees, equivalent requirement and 7+ years relevant experience, or advanced degree with 5+ years.

Responsibilities

• 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 efficient and productive layout.
• Specifies procedures for fabrication of tools and equipment affecting product performance.
• Adapts machine or equipment design to factory and production conditions.
• Incorporates inspection and test requirements into production plan; ensures product quality.
• Leads process validations, equipment qualifications, and manufacturing changes in compliance with regulations.

Skills

OEE analysis

Process Validation

Root Cause Analysis

Technical decision making

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

SAP

MES

AutoCAD

SolidWorks

Minitab

Document Management System

Job description

Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations. This role serves as the primary engineering lead responsible for process validations, process performance, equipment reliability, product quality, capacity expansion, and continuous improvement initiatives. They collaborate cross-functionally with Operations, Quality, Supply Chain, Research & Development, Regulatory Affairs, and Manufacturing Engineering teams to support commercial production, new product introductions and operational excellence objectives.

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.
• Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.
• Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
• Identify and mitigate technical risks impacting safety, quality, delivery, or manufacturing continuity.
• Support new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up.
• Provide technical oversight for capital equipment projects, automation initiatives, and facility upgrades.
• Analyze and report manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).
• Serve as the primary technical escalation point and owner for technical strategy, operational performance, product launch and hypercare of the manufacturing line.
• Mentor and guide manufacturing engineers, process engineers, and cross-functional team members

Job Requirements

Requires mastery of a specialty area and full knowledge of industry practices and knowledge of project management, typically obtained through advanced education combined with experience. 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.

• Semi - automated manufacturing equipment and assembly systems, PLC-controlled equipment and machine interfaces, vision inspection systems, welding plastic injection molded parts, OEE analysis
• Process Validation, Test Method Validation, Change Control management, Statistical Analysis, Root Cause Analysis, Capacity Planning, Yield Improvement, Scrap Reduction
• Technical decision making, project planning and execution to goals, resource prioritization

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