Principal Quality Engineer - Process Development (Medical Devices)

Location: Los Angeles, California, United States of America; on-site. Other listed location: San Diego, California, United States of America.

Salary: $121,000–$205,000 USD annually for California locations.

Company

hirify.global is a full-stack insulin delivery company developing intelligent dosing systems, predictive insights, and support solutions for people living with diabetes.

What you will do

• Develop process characterization, P-diagram, Input-Process-Output, test method validation, and Master Validation strategies for new product introductions and production scale-up.
• Apply DRM, DFSS, DFMA, and COS methods and integrate qualification parts into process development.
• Facilitate pFMEA and analyze design-risk documentation, escalating design implications to Design Quality Assurance partners.
• Lead A3, fishbone, 5-Why, brainstorming, and other root cause investigations for supplier and manufacturing issues.
• Collaborate with R&D, NPI, Supplier Quality, vendors, and manufacturing teams on design transfer, control plans, inspections, drawing reviews, production holds, and commercialization.
• Perform Minitab-based statistical analyses and generate process capability reports to support process development and production readiness decisions.

Requirements

• Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field and 5+ years of process development or manufacturing engineering experience in medical devices; or bachelor's degree in a related engineering field and 7+ years of such experience.
• Experience creating or overseeing complex IQ/OQ/PQ and TMV strategies for medical devices is highly desired, with 7+ years preferred.
• Mastery of ISO 14971 and pFMEA, including linking process risks to design controls, is highly desired.
• Strong knowledge of statistical methods including DOEs, capability studies, and Gage R&R.
• Working knowledge of FDA QSR, 21 CFR Part 820, and ISO 13485.
• Experience influencing cross-functional peers and guiding technical root cause investigations.
• Experience supporting low- to mid-volume electromechanical production lines or wearable medical devices.
• CQE or Six Sigma Black Belt certification is highly desired.

Culture & Benefits

• Full-time on-site role with regular interaction with peers and co-workers and independent mobility required.
• Regular employees working 20 or more hours per week may receive health, dental, vision, HSA, FSA, life insurance, disability, and dependent-care benefits.
• Benefits include paid time off, holidays, 401(k) with company match, incentive plans, employee stock purchase participation, and an employee assistance program.
• Additional retirement and capital accumulation plans may be available subject to eligibility requirements.

Hiring process

• The anticipated application window closes on 9 November 2026.
• Employment consideration includes applicable Los Angeles County and California fair-chance requirements regarding criminal history.