Product Test Engineer II (Medical Devices)

Location: Northridge, California, United States; onsite presence required the majority of the time, with some flexibility for hybrid work.

Salary: $68,000–$116,000 USD annual.

Company

hirify.global develops intelligent insulin delivery systems and predictive diabetes-care technologies for people living with diabetes.

What you will do

• Develop and execute design verification and test strategies for electromechanical medical device programs from design planning through design transfer.
• Develop test methods using simulated real-world environments to evaluate product safety and reliability.
• Apply hypothesis testing, DOE, regression, capability analysis, and other statistical techniques to validate methods, characterize designs, investigate root causes, and demonstrate reliability.
• Contribute to DFMEA, PFMEA, Hazard Analysis, change control, and quality decisions across engineering groups.
• Author and maintain test protocols, engineering reports, standard operating procedures, laboratory notebooks, and performance analyses.
• Support CAPA investigations, post-market analysis, regulatory audits, and cross-functional project teams.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a closely related engineering discipline with 2+ years of relevant experience, or an advanced degree with 0+ years of relevant experience.
• Direct experience with technical documentation, including engineering reports, standard operating procedures, test protocols, and laboratory or engineering notebooks.

Nice to have

• Experience in an FDA-regulated or similarly regulated medical device or cGMP environment.
• Familiarity with quality systems, design controls, good manufacturing practices, and standards including 21 CFR 820, IEC 60601-1, IEC 60601-2-24, ISO 13485, ISO 11608, and ISO 14971.
• Hands-on design verification testing, test method development, and test method validation experience.
• Familiarity with 5-Why, Fishbone, and Fault Tree root cause analysis tools.
• Proficiency with MATLAB, Minitab, or Weibull++ and experience with NI LabVIEW.
• Experience with fixture design, prototyping, and SolidWorks or similar 3D modeling tools.
• Knowledge of electromechanical devices, battery-powered devices, and/or electrochemical reactions.
• Strong written and verbal communication, cross-functional collaboration, organization, prioritization, and focus on quality and customer experience.

Culture & Benefits

• Hands-on, collaborative laboratory environment with cross-functional work across R&D, Operations, Regulatory, and Quality.
• Onsite work is required most of the time, with some hybrid flexibility.
• Competitive compensation with eligibility for a short-term incentive plan.
• Benefits for regular employees working 20 or more hours per week include health, dental, vision, HSA, FSA, life and disability insurance, paid time off, holidays, and a 401(k) with company match.
• Additional benefits include an employee stock purchase plan, employee assistance program, and other eligible retirement and accumulation plans.