Technical Lead, Manufacturing Line - NPI & Process

Intepros; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intepros seeks a Technical Lead, Manufacturing Line to provide engineering leadership for safe, compliant, efficient, and reliable manufacturing operations in California, with onsite locations in Northridge or San Diego. You will lead process validation, equipment qualification, and manufacturing changes while supporting NPI, line readiness, tech transfer, and scale-up.

This role requires strong cross-functional collaboration and a track record in medical device manufacturing or other regulated

Qualifications

• Demonstrated leadership in manufacturing engineering and NPI, with strong process validation and equipment qualification experience.
• Knowledge of FDA QSR and ISO 13485 requirements for medical devices.
• Experience with lean/continuous improvement and OEE to drive manufacturing efficiency.

Responsibilities

• Lead process validations, equipment qualifications, and manufacturing changes.
• Support NPI, process development, line readiness, tech transfer, and scale-up.
• Develop and optimize manufacturing processes, layouts, and production methods.
• Collaborate with Operations, Quality, R&D, Regulatory, and Supply Chain.
• Ensure compliance with FDA QSR, ISO 13485 and internal procedures.
• Troubleshoot issues and lead root-cause and corrective actions.
• Identify and mitigate risks impacting safety, quality, delivery, and continuity.
• Provide leadership for capital equipment, automation, and facility upgrades.
• Analyze manufacturing metrics like yield, capacity, throughput, LBM, and OEE.
• Drive CI and manufacturing efficiency initiatives.
• Serve as escalation point for line, including launches and post-launch support.
• Mentor and guide manufacturing and process engineers.

Skills

Manufacturing leadership

NPI

Process validation

FDA QSR

ISO 13485

Lean/CI

Root-cause analysis

Cross-functional leadership

Medical device manufacturing

Communication

Job description

Intepros seeks a Technical Lead, Manufacturing Line to provide engineering leadership for safe, compliant, efficient, and reliable manufacturing operations in California, with onsite locations in Northridge or San Diego. You will lead process validation, equipment qualification, and manufacturing changes while supporting NPI, line readiness, tech transfer, and scale-up.

This role requires strong cross-functional collaboration and a track record in medical device manufacturing or other regulated