Senior Manufacturing Engineer: Process Validation & Automation

Integrated Resources, Inc ( IRI ); Los Angeles (CA); On-site; USD 156,000 - 166,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) in Los Angeles, CA seeks a Senior Manufacturing Engineer to own process validations, drive improvements, and ensure quality for medical device production. You will develop, validate, and optimize processes, ensuring compliance with FDA/QSR and ISO 13485 standards.

This role partners with internal and external teams to resolve technical challenges, expand capacity, and improve yield and reliability, with up to 40% travel and a path to full-time employment.

Qualifications

• Requires a Baccalaureate degree and 4+ years of relevant experience or advanced degree with 2+ years.
• Experience supporting medical device manufacturing operations.
• Strong understanding of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control methodologies.
• Ability to travel up to 40%.

Responsibilities

• Own manufacturing processes and validations to meet yield, capacity, throughput, reliability and quality goals.
• Develop, validate, implement, and optimize manufacturing processes for quality and regulatory compliance.
• Lead root cause investigations using structured problem solving (5 Why, Fishbone, statistics).
• Provide guidance on design concepts and specification requirements to best utilize equipment.
• Support automation initiatives and advanced manufacturing technologies.
• Collaborate with internal and external stakeholders to meet production objectives.

Skills

Manufacturing process validation

Equipment qualification

Statistical analysis

Process control methodologies

Project management

Travel readiness

Education

Bachelor's degree in a relevant field

Tools

Microsoft Office

SAP

MES

AutoCAD

SolidWorks

Minitab

Document Management System

Job description

Integrated Resources, Inc ( IRI ) in Los Angeles, CA seeks a Senior Manufacturing Engineer to own process validations, drive improvements, and ensure quality for medical device production. You will develop, validate, and optimize processes, ensuring compliance with FDA/QSR and ISO 13485 standards.

This role partners with internal and external teams to resolve technical challenges, expand capacity, and improve yield and reliability, with up to 40% travel and a path to full-time employment.