Manufacturing Engineer

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

Duration: 12 months+ (Possibility to convert FTE)

Pay Range: $75-$80/hr

Job Description:

Responsibilities:

• 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.

Required Skills:

• 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