Principal Leak-Test & Test Systems Engineer

Lancesoft; San Diego (CA); On-site; USD 120,000 - 165,000; Full time

Job summary

LanceSoft is seeking a Technical Specialist in San Diego to advance leak-test systems across manufacturing lines. The role focuses on design, validation, and implementation of test equipment from concept through production, compliant with FDA/ISO standards.

You will collaborate with R&D, Quality, and Regulatory teams to ensure robust testing, process improvements, and equipment performance in a medical device environment.

Qualifications

• Must have strong background in pressure decay leak test system design and validation.
• Experience with IQ/OQ/PQ in compliance with FDA and ISO regulations.
• Ability to lead process development and validation activities for test equipment.
• Familiarity with conducting MSA/Gauge R&R studies.

Responsibilities

• Design manufacturing processes and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Define test specifications, acceptance criteria, and test parameters with R&D, Quality, and Regulatory teams.
• Lead the process development, qualification, and validation of test equipment (IQ/OQ/PQ).
• Develop and execute validation studies including repeatability and reproducibility.
• Drive continuous improvement to optimize test yield, cycle time, and rejection rates.

Skills

Technical leadership

Analytical thinking

Problem solving

Regulatory awareness

Education

Bachelor's degree or equivalent

Advanced degree (MS/PhD)

Tools

Uson

Zaxis

Inficon

MES integration

Job description

LanceSoft is seeking a Technical Specialist in San Diego to advance leak-test systems across manufacturing lines. The role focuses on design, validation, and implementation of test equipment from concept through production, compliant with FDA/ISO standards.

You will collaborate with R&D, Quality, and Regulatory teams to ensure robust testing, process improvements, and equipment performance in a medical device environment.