Principal Engineer - Product Testing (Medical Devices)

Location: Full-time on-site role in Northridge, California, United States, with willingness and ability to travel for business 25–40% of the time depending on project needs.

Salary: $121,000–$205,000 USD for roles located in California.

Company

hirify.global is a full-stack insulin delivery company developing intelligent dosing systems and predictive diabetes-care solutions.

What you will do

• Own and lead the design, implementation, qualification, validation, and optimization of pressure decay leak test systems and electrical/mechanical test systems across manufacturing lines.
• Design manufacturing processes, production layouts, machine arrangements, operating sequences, tools, and equipment specifications.
• Lead IQ/OQ/PQ qualification and validation of test equipment in compliance with FDA and ISO requirements.
• Define test specifications, acceptance criteria, and test parameters with R&D, Quality, and Regulatory teams.
• Troubleshoot complex test failures, perform root cause analysis, and implement sustainable corrective actions.
• Improve test yield, cycle time, false rejection rates, throughput, capacity, and overall equipment effectiveness using manufacturing performance metrics.

Requirements

• Bachelor’s degree with at least 7 years of relevant experience, or an advanced degree with 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 have

• Experience owning technical strategy, operational performance, and long-term production process optimization.
• Familiarity with MES integration 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.

Culture & Benefits

• Full-time on-site work in Northridge with business travel of 25–40% depending on project needs.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account access.
• Life insurance, disability coverage, paid time off, and paid holidays.
• 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Program, and other eligible retirement benefits.
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.