Principal Engineer - Product Testing

MiniMed•Northridge, CA

4d•Onsite

About The Position

MiniMed is seeking a highly specialized subject matter expert to lead pressure decay leak-test systems and transmission-test design, implementation, validation, and optimization across manufacturing lines. The Principal Engineer serves as the technical authority for pressure decay leak-test systems and electrical and mechanical test systems, ensuring testing processes produce consistent, reliable, and compliant results throughout production. This is a full-time, on-site role in Northridge, California, with business travel of 25–40% depending on project needs. The role leads test-equipment process development, qualification, and validation in compliance with FDA and ISO regulations; defines test specifications and acceptance criteria with R&D, Quality, and Regulatory teams; and resolves complex test failures through root-cause analysis and sustainable corrective actions. The engineer also evaluates test technologies, validates test methods, and drives improvements to yield, cycle time, false rejection rates, throughput, efficiency, and overall equipment effectiveness. MiniMed describes itself as a full-stack insulin delivery company focused on supporting people living with diabetes. It offers competitive compensation and a flexible benefits package. The stated U.S. salary range is $109,000–$185,000, with a range of $121,000–$205,000 for roles located in California and certain other listed locations. Actual compensation may vary based on experience, education, certifications, skills, market conditions, internal equity, and geographic location.

Requirements

Bachelor’s degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of relevant experience.
Experience with alternative leak-test methodologies, such as mass flow, helium, or vacuum decay.
Experience with industry-leading leak-test equipment, such as 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.

Nice To Haves

Experience owning technical strategy, operational performance, and production-process optimization for long-term sustainability.
Familiarity with integrating Manufacturing Execution Systems (MES) with test equipment.
Experience with fluid dynamics, pneumatics, and hermetic-sealing principles.
Experience supporting contract manufacturers in a medical-device environment.
Six Sigma Green Belt or Black Belt certification.
Experience with pump or infusion-device manufacturing.

Responsibilities

Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, and material handling.
Design machine arrangements within plant facilities to promote efficient and productive layouts.
Design sequences of operations and specify procedures for fabricating tools and equipment that affect product performance.
Adapt machine or equipment designs to factory and production conditions.
Develop manufacturing processes applicable to statistical process control and, where appropriate, develop those techniques.
Guide engineering teams on design concepts and specification requirements to make effective use of equipment and manufacturing techniques.
Lead test-equipment process development, qualification, and validation (IQ/OQ/PQ) in compliance with FDA and ISO regulations.
Define test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
Troubleshoot complex test failures, conduct root-cause analysis, and implement sustainable corrective actions.
Evaluate and recommend test technologies and methodologies to improve test capability and manufacturing efficiency.
Develop and execute test-method validation studies, including repeatability, reproducibility, and measurement-system analysis (Gauge R&R/TMV).
Incorporate inspection and test requirements into production plans.
Inspect machinery, equipment, and tools to verify performance and efficiency; investigate problems and deficiencies and initiate corrective action to ensure product quality.
Drive continuous-improvement initiatives to optimize test yield, cycle time, and false rejection rates.
Analyze manufacturing performance metrics, including LBM, yield, and capacity, and develop action plans to improve throughput, efficiency, and overall equipment effectiveness (OEE).
Travel for business 25–40% of the time, depending on project needs.