Senior Principal Engineer - Leak Test Systems & Validation

MiniMed; Los Angeles (CA); On-site; USD 109,000 - 205,000; Full time

Benefits offered by this job

Health, dental, vision insurance

401(k) with company match

Paid time off

Job summary

MiniMed is seeking a highly specialized expert to own and lead pressure decay leak test systems and related test design across manufacturing lines. You will act as the technical authority ensuring testing processes deliver reliable, compliant results throughout production.

The role requires designing, validating, and optimizing test equipment, collaborating with R&D, Quality, and Regulatory teams, and driving continuous improvement. On-site in Northridge, CA with 25–40% travel.

Qualifications

• Must have: Bachelor’s degree with 7+ years of relevant experience or Advanced degree with 5+ years of relevant experience.
• Experience with alternative leak test methodologies (mass flow, helium, vacuum decay).
• Experience with industry-leading leak test equipment (Uson, Zaxis, Inficon or equivalent).
• Experience with medical device manufacturing, process validation, quality systems, and regulatory requirements.
• Experience with root cause analysis, statistical methods, and manufacturing process optimization.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment.
• Adapts machine or equipment design to factory and production conditions.
• Develops manufacturing processes applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements.
• Leads the process development, qualification and validation of test equipment (IQ/OQ/PQ) in compliance with FDA and ISO regulations.
• Defines test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
• Troubleshoots and resolves complex test failures, driving root cause analysis and implementing sustainable corrective actions.
• Evaluates and recommends new test technologies and methodologies to enhance test capability and manufacturing efficiency.
• Develops and executes test method validation studies, including repeatability, reproducibility, and measurement system analysis (Gauge R&R/TMV).
• Incorporates 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.
• Drives continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates.
• Analyzes manufacturing performance metrics like LBM, yield, capacity and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).

Skills

Pressure decay leak testing

Test system design

Root cause analysis

Statistical methods

Process optimization

Project leadership

Education

Bachelor's degree in engineering or related field

Advanced degree in engineering or related field

Tools

Uson equipment

Zaxis equipment

Inficon equipment

Job description

MiniMed is seeking a highly specialized expert to own and lead pressure decay leak test systems and related test design across manufacturing lines. You will act as the technical authority ensuring testing processes deliver reliable, compliant results throughout production.

The role requires designing, validating, and optimizing test equipment, collaborating with R&D, Quality, and Regulatory teams, and driving continuous improvement. On-site in Northridge, CA with 25–40% travel.