Technical Lead - Manufacturing Line

MiniMed•Northridge, CA

3d•Onsite

About The Position

Step into a role where your technical leadership directly powers the safety, quality, and performance of our manufacturing operations. As the primary engineering lead for our production line, you will be the driving force behind process validation, equipment reliability, product quality, and capacity expansion — while championing the continuous improvement initiatives that keep us at the forefront of manufacturing excellence. In this high-visibility role, you will collaborate across Operations, Quality, Supply Chain, R&D, Regulatory Affairs, and Manufacturing Engineering — bridging strategy and execution to support new product introductions, commercial launch, production and a relentless pursuit of operational excellence.

Requirements

Bachelor’s degree in Engineering with minimum of 7+ years of relevant experience, or Advanced degree in Engineering with a minimum of 5+ years of relevant experience.
Experience in medical device manufacturing, process validation, quality systems, and regulatory requirements.
Experience with cause analysis, statistical methods, and manufacturing process optimization.
Able and willing to travel for business 25-40% of the time depending on project needs

Nice To Haves

Six Sigma Green Belt or Black Belt certification
Experience with pump, implantable device or infusion device manufacturing
Experience supporting Contract Manufacturers in a medical device environment
Familiarity with MES (Manufacturing Execution Systems) integration with equipment
Demonstrated experience for owning technical strategy, operational performance, and long-term sustainability of production process
Knowledge of fluid dynamics, pneumatics, hermetic sealing, leak testing principles
Knowledge of plastic joining technologies (e.g., laser welding, ultrasonic welding, heat staking, vibration welding) for comparative process selection
Knowledge of weld inspection techniques including cross-sectional analysis, tensile/burst testing, and non-destructive evaluation
Familiarity with GD&T and optical measurement principles, troubleshoot and resolve complex vision system failures

Responsibilities

Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling.
Design arrangement of machines within plant facilities to ensure most efficient and productive layout.
Design sequence of operations and specifies procedures for the operation of tools and equipment and adapts machine or equipment design to factory and production conditions.
Develop manufacturing processes that are applicable to statistical process control and may develop those techniques.
Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Develop and execute manufacturing strategies to support production growth, operational excellence, and business objectives.
Lead new product introduction (NPI) activities, including process development, line readiness, technology transfer, and manufacturing scale-up.
Lead process validations, equipment qualifications, and implementation of manufacturing changes in compliance with regulatory requirements.
Lead troubleshooting and resolution of complex manufacturing, equipment, process, and product quality issues.
Identify and mitigate technical risks impacting safety, quality, delivery, or manufacturing continuity.
Incorporate inspection and test requirements into the production plan.
Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Drive continuous improvement initiatives focused on yield enhancement, scrap reduction, cycle-time improvements, and capacity optimization.
Analyze manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).
Partner with Operations and Quality teams to ensure compliance with FDA Quality System Regulations, ISO 13485 requirements, and company procedures.
Provide technical oversight for capital equipment projects, automation initiatives, and facility upgrades.
Mentor and guide manufacturing engineers, process engineers, technicians.
Serve as the primary technical escalation point for production issues and critical technical decisions impacting business goals.