Senior Test Engineer (Medical Devices)

Location: Northridge, California, United States of America; On-Site

Salary: $97,000–$165,000 USD per year

Company

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

What you will do

• Lead the architecture, design, development, qualification, and validation of automated test equipment, functional test systems, fixtures, and manufacturing test systems.
• Design hardware including custom PCBs, electrical interfaces, signal-conditioning circuits, bed-of-nails fixtures, and integrations with commercial test instruments.
• Develop automated test software, firmware, test executive frameworks, operator GUIs, data logging, statistical analysis, and database integrations using platforms such as LabVIEW, TestStand, Python, C#, or similar.
• Define test strategies, coverage matrices, acceptance criteria, Design for Testability activities, escape-risk mitigation, Gauge R&R studies, and measurement uncertainty analyses.
• Support NPI, pilot builds, production ramps, equipment troubleshooting, calibration, ECOs, operator training, yield analysis, and continuous improvement.
• Act as a technical SME, lead design reviews and cross-functional programs, mentor engineers and technicians, and drive automation, digitalization, predictive maintenance, and test-cost improvements.

Requirements

• Bachelor’s degree and at least 4 years of relevant experience, or an advanced degree and at least 2 years of relevant experience.
• Experience designing and developing manufacturing test equipment, including test fixtures, hardware, analog and digital circuits, and measurement systems.
• Experience developing automated test software with LabVIEW, TestStand, Python, C#, C++, or similar technologies.
• Knowledge of test equipment validation, including IQ/OQ/PQ, FDA 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, and measurement-system capability.
• Ability to lead test equipment projects from concept through validation and production deployment in a regulated environment.
• Experience with documentation, requirements traceability, calibration, risk management, data analysis, and production test integration.
• Strong analytical, problem-solving, written and verbal communication, project management, cross-functional collaboration, and influencing skills.
• Ability to mentor junior and mid-level engineers and technicians and present technical information to senior leadership.

Nice to have

• 8–12+ years of progressive manufacturing test equipment experience and at least 5 years in regulated medical device, aerospace, or defense manufacturing.
• Experience with implantable or active medical devices, RF and wireless testing, machine vision, environmental stress screening, HALT/HASS, ESD, IPC-A-610, and FDA or Notified Body audits.
• Experience integrating NI, Keysight, or Tektronix instruments, MES and ERP systems, Industry 4.0 or IoT manufacturing solutions, and PCB designs using Altium or Cadence.
• Knowledge of Six Sigma, Lean Manufacturing, Gauge R&R, and measurement systems analysis.
• Master’s degree in Electrical Engineering, Computer Engineering, or a related field.
• NI Certified LabVIEW Architect, NI Certified TestStand Developer, Six Sigma Green or Black Belt, or PMP certification.

Culture & Benefits

• Full-time, on-site role supporting medical device manufacturing and insulin delivery products.
• Competitive salary and flexible benefits package for U.S. employees.
• Health, dental, vision, HSA, FSA, life insurance, disability coverage, paid time off, and holidays.
• 401(k) with company match, employee stock purchase plan, employee assistance program, and additional eligible retirement and capital accumulation plans.
• Reasonable accommodations are available for qualified individuals with disabilities.