Principal Pressure Decay Test Systems Engineer

Planet Pharma; San Diego (CA); On-site; USD 177,000 - 218,000; Full time

Job summary

Planet Pharma in San Diego, CA seeks a technical specialist with deep expertise in pressure decay leak testing and electrical-mechanical testing systems to lead design, validation, and optimization across manufacturing lines.

The role includes defining test specs with R&D, Quality and Regulatory, developing IQ/OQ/PQ programs, and driving continuous improvements to test yield and cycle times in a medical device environment.

Qualifications

• Hands-on experience with industry-leading leak test equipment (e.g., Uson, Zaxis, Inficon, or equivalent).
• Experience with fluid dynamics, pneumatics, and hermetic sealing principles.
• Experience in development & validation of electrical-mechanical testing systems.
• Familiarity with MES integration with test equipment.
• Experience supporting Contract Manufacturers in a medical device environment.
• Knowledge of alternative leak test methodologies (e.g., mass flow, helium, vacuum decay).
• Six Sigma Green Belt or Black Belt certification.
• Experience with pump or infusion device manufacturing.

Responsibilities

• 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 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.

Skills

Leak test equipment

Fluid dynamics

Pneumatics

Electrical-mechanical testing

MES integration

Six Sigma

Medical device environment

Contract manufacturers support

Alternative leak test methods

Infusion devices

Education

Baccalaureate degree

Tools

Uson

Zaxis

Inficon

MES (Manufacturing Execution Systems)

Job description

Planet Pharma in San Diego, CA seeks a technical specialist with deep expertise in pressure decay leak testing and electrical-mechanical testing systems to lead design, validation, and optimization across manufacturing lines.

The role includes defining test specs with R&D, Quality and Regulatory, developing IQ/OQ/PQ programs, and driving continuous improvements to test yield and cycle times in a medical device environment.