Principal Manufacturing Engineer - Pressure Decay Leak Testing & Test Systems

Intepros; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intepros is seeking a Principal Test Engineer with deep expertise in pressure decay leak testing and electrical/mechanical test systems to support development, validation, troubleshooting, and continuous improvement in a medical device manufacturing environment.

You will serve as SME across manufacturing lines, define test specs with R&D, Quality and Regulatory, and lead IQ/OQ/PQ validations to FDA/ISO standards, plus TMV studies and measurement analysis to drive yield and cycle-time

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 5+ years of relevant experience.
• Demonstrated mastery of a technical specialty and strong knowledge of industry practices.
• Broad knowledge of project management and experience leading complex technical initiatives.
• Hands-on experience with pressure decay leak testers and electrical/mechanical testing systems.

Responsibilities

• Serve as SME for pressure decay leak test system design, validation, and optimization.
• Define test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
• Lead the development, qualification, and validation of test equipment, including IQ/OQ/PQ, in compliance with applicable FDA and ISO requirements.
• Develop and execute Test Method Validation (TMV) studies, including repeatability, reproducibility, Measurement System Analysis (MSA), and Gauge R&R.
• Drive continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates.
• Evaluate and recommend new test technologies and methodologies to improve inspection capability, reliability, and manufacturing efficiency.
• Troubleshoot and resolve complex test-system failures through root cause analysis and sustainable corrective actions.
• Collaborate with Engineering, Quality, R&D, Regulatory, Manufacturing, and external partners to implement robust testing solutions.

Skills

Pressure decay testing

Electrical testing

Mechanical testing

Project management

Troubleshooting

Education

Bachelor's degree

Advanced degree

Tools

Uson

Zaxis

INFICON

Job description

Principal Test Engineer – Pressure Decay & Electrical/Mechanical Testing

We’re actively seeking an experienced Principal Test Engineer with deep expertise in pressure decay leak testing and electrical/mechanical test systems to support test system development, validation, troubleshooting, and continuous improvement within a medical device manufacturing environment.

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or an advanced degree with 5+ years of relevant experience.
• Demonstrated mastery of a technical specialty and strong knowledge of industry practices.
• Broad knowledge of project management and experience leading complex technical initiatives.
• Hands-on experience with pressure decay leak testers and electrical/mechanical testing systems.

Key Responsibilities

• Serve as the primary Subject Matter Expert (SME) for pressure decay leak test system design, implementation, validation, and optimization across manufacturing lines.
• Define test specifications, acceptance criteria, and test parameters in collaboration with R&D, Quality, and Regulatory teams.
• Lead the development, qualification, and validation of test equipment, including IQ/OQ/PQ, in compliance with applicable FDA and ISO requirements.
• Develop and execute Test Method Validation (TMV) studies, including repeatability, reproducibility, Measurement System Analysis (MSA), and Gauge R&R.
• Drive continuous improvement initiatives to optimize test yield, cycle time, and false rejection rates.
• Evaluate and recommend new test technologies and methodologies to improve inspection capability, reliability, and manufacturing efficiency.
• Troubleshoot and resolve complex test-system failures through root cause analysis and sustainable corrective actions.
• Collaborate with Engineering, Quality, R&D, Regulatory, Manufacturing, and external partners to implement robust testing solutions.

Preferred Qualifications

• Hands-on experience with leading leak test equipment, such as Uson, Zaxis, INFICON, or equivalent systems.
• Strong understanding of fluid dynamics, pneumatics, and hermetic sealing principles.
• Experience developing and validating electrical/mechanical testing systems.
• Familiarity with MES integration and connectivity between manufacturing execution systems and test equipment.
• Experience supporting Contract Manufacturers (CMs) in a medical device manufacturing environment.
• Knowledge of alternative leak-test methodologies, including:
• Mass flow
• Helium leak testing
• Vacuum decay
• Six Sigma Green Belt or Black Belt certification is a plus.
• Experience supporting pump, infusion, or similar medical device manufacturing is highly preferred.