Senior Medical Device Manufacturing Engineer — Process & Automation

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

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