Sr Manufacturing Engineer

Intepros; Los Angeles (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

Intepros is seeking a Senior Manufacturing Engineer in Northridge, CA to advance process development, validation, and continuous improvement within a regulated medical device environment. You will own manufacturing processes, design layouts, validate equipment, and lead root-cause analyses while collaborating with cross-functional teams to meet FDA QSR and ISO 13485 requirements.

The role emphasizes quality, yield, throughput, and reliability, with opportunities to impact ramp-up and

Qualifications

• Senior-level manufacturing engineering experience.
• Experience with medical device manufacturing or another regulated industry.
• Strong knowledge of process validation, equipment qualification, and continuous improvement.
• Experience with automation, manufacturing equipment, and root-cause/problem-solving methodologies.
• Familiarity with FDA QSR and ISO 13485 requirements.

Responsibilities

• Own and optimize manufacturing processes to improve yield, throughput, capacity, quality, and reliability
• Design and implement manufacturing processes, layouts, semi-automated equipment, and material handling systems
• Develop and execute equipment and process validations (IQ/OQ/PQ)
• Develop and maintain process specifications, work instructions, and engineering documentation
• Support automation and advanced manufacturing technologies
• Troubleshoot complex manufacturing and quality issues and serve as a technical escalation point
• Lead root-cause investigations using 5 Why, Fishbone, and statistical analysis
• Drive initiatives to reduce scrap, improve efficiency, and optimize labor utilization
• Partner with equipment suppliers and cross-functional teams to improve equipment capability and reliability
• Support commercial production ramp-up and identify/eliminate manufacturing bottlenecks
• Ensure processes comply with FDA Quality System Regulations, ISO 13485, and internal procedures

Job description

Senior Manufacturing Engineer

Northridge, CA

We’re seeking Manufacturing Engineers to support manufacturing process development, validation, equipment readiness, commercialization, and continuous improvement within a regulated medical device environment.

Responsibilities

• Own and optimize manufacturing processes to improve yield, throughput, capacity, quality, and reliability
• Design and implement manufacturing processes, layouts, semi-automated equipment, and material handling systems
• Develop and execute equipment and process validations (IQ/OQ/PQ)
• Develop and maintain process specifications, work instructions, and engineering documentation
• Support automation and advanced manufacturing technologies
• Troubleshoot complex manufacturing and quality issues and serve as a technical escalation point
• Lead root-cause investigations using 5 Why, Fishbone, and statistical analysis
• Drive initiatives to reduce scrap, improve efficiency, and optimize labor utilization
• Partner with equipment suppliers and cross-functional teams to improve equipment capability and reliability
• Support commercial production ramp-up and identify/eliminate manufacturing bottlenecks
• Ensure processes comply with FDA Quality System Regulations, ISO 13485, and internal procedures

Ideal Background

• Senior-level manufacturing engineering experience
• Experience with medical device manufacturing or another highly regulated industry
• Strong knowledge of process validation, equipment qualification, and continuous improvement
• Experience with automation, manufacturing equipment, and root-cause/problem-solving methodologies
• Familiarity with FDA QSR and ISO 13485 requirements