Manufacturing Engineer

ATR International; Los Angeles (CA); Hybrid; USD 100,000 - 150,000; Full time

Job summary

ATR International seeks a Senior Manufacturing Engineer to own technical processes, validate and optimize manufacturing methods, and drive continuous improvement. Hybrid in Northridge, CA, this role focuses on process validation, equipment readiness, capacity expansion, and quality goals for medical device manufacturing.

The candidate will develop, validate, implement, and optimize processes and documentation, with strong interaction across internal and external teams, including regulatory

Qualifications

• Requires advanced knowledge of manufacturing processes and validation with 4+ years of related experience.
• Experience supporting medical device manufacturing operations and strong problem-solving skills.
• Travel up to 40% and ability to work in a hybrid environment.

Responsibilities

• Designs and validates manufacturing processes and layouts for semi-automation equipment.
• Leads process validation (IQ/OQ/PQ) and test method development.
• Acts as escalation point for complex manufacturing and quality issues.
• Drives yield improvements, scrap reduction, and throughput optimization.
• Ensures compliance with FDA QSR, ISO 13485, and company procedures.

Skills

Statistical analysis

Root cause investigations

Project management

Continuous improvement

Education

Bachelor's degree in Engineering

Tools

SAP

AutoCAD

SolidWorks

Minitab

MES

Microsoft Office

Document Management System

Job description

1 year contract (could extend or convert)

Hybrid in Northridge, CA

The Senior Manufacturing Engineer serves as the technical process owner responsible for manufacturing process validations, performance, equipment readiness, capacity expansion, and continuous improvement activities to meet the yield, capacity, throughput, reliability and quality goals. This role drives the development, validation, implementation, and optimization of manufacturing processes to ensure product quality, regulatory compliance, operational excellence, and successful commercialization. This role partners closely with internal and external stakeholder teams to support production objectives, resolve technical challenges, and execute strategic initiatives that improve manufacturing capability, efficiency, and reliability. Responsibilities may include the following and other duties may be assigned.

• Designs manufacturing processes, procedures and production layouts for semi automation equipment installation, processing and material handling.
• Adapts machine or equipment design to factory and production conditions, 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 and maintains manufacturing process specifications, work instructions, and engineering documentation
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Develop and execute equipment and process validation activities, including IQ, OQ, and PQ protocols and test method development and validation
• Supports automation initiatives and advanced manufacturing technologies
• Serve as the primary technical escalation point for complex manufacturing and quality issues.
• Lead root cause investigations utilizing structured problem-solving tools such as 5 Why, Fishbone Analysis, and Statistical Analysis.
• Lead initiatives to improve yield, reduce scrap, increase throughput, and optimize labor utilization.
• Partner with equipment suppliers and internal stakeholders to improve equipment capability and reliability.
• Develop manufacturing strategies for commercial production ramp-up, identify and eliminate bottlenecks impacting manufacturing performance.
• Ensures processes and procedures are in compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Requirements

Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical 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 of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Experience supporting medical device manufacturing operations. Strong understanding of manufacturing process validation and equipment qualification. Experience with statistical analysis and process control methodologies.

Able to travel up to 40%

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