Technical Lead, Manufacturing Line

Lancesoft; San Diego (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

LanceSoft in San Diego, CA, seeks a senior manufacturing engineering leader to drive production line performance and ensure safe, compliant, and efficient operations for commercial production and new product introductions.

You will design processes and layouts, lead validations and qualifications, collaborate with quality, R&D, regulatory affairs, and manufacturing teams, and monitor metrics like OEE, yield, and capacity to support continuous improvement.

Qualifications

• Leads process validations, equipment qualifications, and implementation of changes in compliance with regulatory requirements.
• Collaborates with Operations, Quality, Supply Chain, R&D, Regulatory Affairs, and Manufacturing Engineering to support production and NPI.
• Monitors manufacturing metrics (OEE, yield, capacity) and drives continuous improvement.

Responsibilities

• Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations.
• Designs manufacturing processes and layouts for assemblies, equipment, and material handling.
• Leads process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.

Job description

Provides technical leadership for production line to ensure safe, compliant, efficient, and reliable manufacturing operations. This role serves as the primary engineering lead responsible for process validations, process performance, equipment reliability, product quality, capacity expansion, and continuous improvement initiatives. They collaborate cross-functionally with Operations, Quality, Supply Chain, Research & Development, Regulatory Affairs, and Manufacturing Engineering teams to support commercial production, new product introductions, and operational excellence objectives. This exciting opportunity is based in the vibrant city of San Diego, CA, known for its beautiful beaches, thriving biotech industry, and perfect year-round climate. Designs manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling. Designs arrangement of machines within plant facilities to ensure the most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. Leads process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements. Partners with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures. Identifies and mitigates technical risks impacting safety, quality, delivery, or manufacturing continuity. Supports new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up. Provides technical oversight for capital equipment projects, automation initiatives, and facility upgrades. Analyzes and reports manufacturing performance metrics like LBM, yield, capacity, and develops action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE). Serves as the primary technical escalation point and owner for technical strategy, operational performance, product launch, and hypercare of the manufacturing line.

EEO Employer LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.