Senior Medical Device Manufacturing Engineer – Process Lead

Redbock - an NES Fircroft company; Los Angeles (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Redbock - an NES Fircroft company is seeking a Senior Manufacturing Engineer for a 12-month contract in Northridge, CA. The role focuses on owning manufacturing processes, validations, equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality targets.

You will drive development, validation, implementation, and optimization of processes, partnering with internal and external teams to address technical challenges and initiatives that enhance

Qualifications

• Experience in medical device operations and line implementation.
• Strong knowledge of process validation and equipment qualification.
• Proven ability in statistical analysis and SPC.
• Familiarity with Lean/Six Sigma methodologies.
• Willingness to travel up to 40%.

Responsibilities

• Design manufacturing processes and layouts for semi-automation equipment.
• Adapt equipment to production conditions and integrate inspection requirements.
• Inspect machinery performance and drive corrective actions for quality.
• Develop process specifications, work instructions and documentation.
• Lead IQ/OQ/PQ validation activities and test method development.
• Support automation initiatives and advanced manufacturing technologies.
• Serve as technical escalation point for manufacturing and quality issues.
• Lead root cause analyses using 5 Why, Fishbone, and statistics.
• Collaborate with suppliers and stakeholders to improve capability and reliability.
• Plan ramp-up strategies and eliminate bottlenecks to meet production goals.
• Ensure compliance with FDA QSR, ISO 13485, and company procedures.

Skills

Medical device manufacturing

Process validation

Statistical analysis

Lean/Six Sigma

Manufacturing process design

Education

Bachelor's degree

Advanced degree

Tools

SAP

MES

AutoCAD

SolidWorks

Minitab

Document Management System

Job description

Redbock - an NES Fircroft company is seeking a Senior Manufacturing Engineer for a 12-month contract in Northridge, CA. The role focuses on owning manufacturing processes, validations, equipment readiness, capacity expansion, and continuous improvement to meet yield, throughput, and quality targets.

You will drive development, validation, implementation, and optimization of processes, partnering with internal and external teams to address technical challenges and initiatives that enhance