Senior Medical Device Manufacturing Engineer – Validation

Redbock - an NES Fircroft company; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Sr. Manufacturing Engineer for a 12-month contract in Northridge, CA, with strong potential for conversion.

You will own manufacturing processes, drive validations, oversee equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality goals. The role partners with internal and external teams to resolve technical challenges, implement automation initiatives, and ensure regulatory compliance (FDA QSR, ISO

Qualifications

• Requires a Baccalaureate degree 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, ideally with automated and semi-automated equipment.
• Strong understanding of manufacturing process validation and equipment qualification.
• Experience with statistical analysis and process control methodologies.
• Able to travel up to 40%.

Responsibilities

• 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 follow FDA Quality System Regulations, ISO 13485 requirements, and company procedures.

Skills

Medical device manufacturing

Lean Six Sigma

Process design & optimization

Problem solving (5 Why, Fishbone, RCA)

Automation equipment experience

NCR/quality issue analysis

Education

Bachelor's degree (Baccalaureate)

Tools

Microsoft Office

SAP

MES

AutoCAD

SolidWorks

Minitab

Document Management System

Job description

Redbock - an NES Fircroft company is seeking a Sr. Manufacturing Engineer for a 12-month contract in Northridge, CA, with strong potential for conversion.

You will own manufacturing processes, drive validations, oversee equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality goals. The role partners with internal and external teams to resolve technical challenges, implement automation initiatives, and ensure regulatory compliance (FDA QSR, ISO