Technical Lead - Manufacturing Line (Medical Devices)

Location: Full-time on-site role in Northridge, California, United States; business travel required 25–40% depending on project needs.

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

Company

hirify.global develops intelligent insulin delivery systems and predictive diabetes-care solutions.

What you will do

• Design manufacturing processes, production layouts, equipment arrangements, operating sequences, and material-handling procedures.
• Develop manufacturing strategies supporting production growth, operational excellence, new product introduction, line readiness, technology transfer, and manufacturing scale-up.
• Lead process validations, equipment qualifications, manufacturing changes, and compliance with FDA Quality System Regulations, ISO 13485, and company procedures.
• Troubleshoot complex manufacturing, equipment, process, and product-quality issues while identifying and mitigating risks to safety, quality, delivery, and continuity.
• Drive improvements in yield, scrap, cycle time, capacity, throughput, efficiency, and overall equipment effectiveness; analyze LBM, yield, and capacity metrics.
• Provide technical oversight for capital equipment, automation, and facility projects; mentor engineers and technicians and act as the primary technical escalation point.

Requirements

• Bachelor’s degree in Engineering with at least 7 years of relevant experience, or an advanced Engineering degree with at least 5 years of relevant experience.
• Experience in medical device manufacturing, process validation, quality systems, and regulatory requirements.
• Experience with cause analysis, statistical methods, and manufacturing process optimization.
• Ability and willingness to travel for business 25–40% of the time depending on project needs.

Nice to have

• Six Sigma Green Belt or Black Belt certification.
• Experience with pump, implantable-device, or infusion-device manufacturing.
• Experience supporting contract manufacturers in a medical device environment.
• Familiarity with MES integration with equipment.
• Experience owning technical strategy, operational performance, and long-term production-process sustainability.
• Knowledge of fluid dynamics, pneumatics, hermetic sealing, and leak-testing principles.
• Knowledge of plastic joining technologies, including laser welding, ultrasonic welding, heat staking, and vibration welding.
• Knowledge of weld inspection techniques, including cross-sectional analysis, tensile or burst testing, and non-destructive evaluation.
• Familiarity with GD&T and optical measurement principles, including troubleshooting complex vision-system failures.

Culture & Benefits

• Full-time on-site work in Northridge, California, with a focus on innovation and improving diabetes care.
• Health, dental, and vision insurance, plus Health Savings Account and Healthcare Flexible Spending Account access.
• Life insurance, short- and long-term disability coverage, dependent daycare spending account, paid time off, and holidays.
• 401(k) plan with company match, incentive plans, Employee Stock Purchase Plan, Employee Assistance Program, and additional retirement programs subject to eligibility.
• Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities.