Senior Medical Device Manufacturing Engineer

Redbock - an NES Fircroft company; Los Angeles (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Redbock - an NES Fircroft company in Los Angeles is seeking a Senior Manufacturing Engineer to own hands-on process validation, equipment readiness, and capacity expansion in a regulated medical device setting.

You will drive continuous improvement, troubleshoot complex issues, lead root-cause analyses, and collaborate across Manufacturing, Quality, Engineering, and Suppliers to boost yield, throughput, and reliability while ensuring compliance with FDA QSR and ISO 13485.

Qualifications

• Bachelor's degree in Engineering or related technical field with 4+ years of experience, or advanced degree with 2+ years of experience.
• Hands-on experience in medical device manufacturing operations.
• Strong experience with manufacturing process validation and equipment qualification (IQ/OQ/PQ).
• Experience troubleshooting manufacturing equipment and driving process improvements in a regulated environment.
• Knowledge of statistical analysis and process control methodologies.
• Experience collaborating with Manufacturing, Quality, Engineering, Operations, and equipment suppliers.
• Familiarity with Minitab, SAP, MES, AutoCAD, SolidWorks, Microsoft Office, and document management systems preferred.

Responsibilities

• Develop, execute, and support manufacturing process and equipment validation (IQ/OQ/PQ).
• Support installation, qualification, and optimization of semi-automated manufacturing equipment and production lines.
• Develop and maintain process specifications, work instructions, validation documentation, and engineering documentation.
• Troubleshoot complex manufacturing, equipment, and quality issues; act as escalation point.
• Lead root cause investigations using 5 Why, Fishbone Analysis, and statistical analysis.
• Drive improvements in yield, scrap reduction, throughput, capacity, equipment reliability, and labor utilization.
• Partner with equipment suppliers and internal teams to improve equipment capability and process performance.
• Support automation initiatives and advanced manufacturing technologies.
• Identify bottlenecks and support ramp-up and capacity expansion.
• Ensure processes comply with FDA Quality System requirements, ISO 13485, and internal procedures.

Skills

Manufacturing process validation

Equipment qualification

Problem solving

Statistical analysis

Cross-functional collaboration

Root cause analysis

Process improvements

Troubleshooting

Project management

Education

Bachelor's degree in Engineering

Master's degree (advantaged)

Tools

Minitab

SAP

MES

AutoCAD

SolidWorks

Microsoft Office

Document management systems

Job description

Redbock - an NES Fircroft company in Los Angeles is seeking a Senior Manufacturing Engineer to own hands-on process validation, equipment readiness, and capacity expansion in a regulated medical device setting.

You will drive continuous improvement, troubleshoot complex issues, lead root-cause analyses, and collaborate across Manufacturing, Quality, Engineering, and Suppliers to boost yield, throughput, and reliability while ensuring compliance with FDA QSR and ISO 13485.