Lead Medical Device Lab Technician – R&D & Verification

MicroPort; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

MicroPort Endovastec MedTech Inc. of Irvine, California, is a medical device company focused on endovascular devices.

The Lead Engineering Laboratory Technician leads daily R&D lab operations, supports design verification testing, and ensures compliance with FDA and ISO 13485 quality systems. You will own laboratory infrastructure, manage equipment, calibration, documentation, and prototype control while coordinating a safe, efficient lab and supporting multiple engineering projects in a

Qualifications

• Associate's or Bachelor's degree in Engineering Technology, Biomedical Engineering, Mechanical Engineering Technology, or related discipline.
• 5+ years of laboratory or engineering technician experience, preferably in medical device R&D.
• Experience with Design Verification testing and regulated environments (FDA/ISO 13485).
• Strong mechanical aptitude, laboratory instrumentation, calibration, documentation, inventory management, and Microsoft Office skills.
• Experience with catheter, stent, stent graft, vascular, or structural heart devices is highly desirable.

Responsibilities

• Coordinate daily laboratory operations and maintain a safe, organized, efficient laboratory.
• Support multiple engineering projects and improve laboratory workflow.
• Set up, configure, troubleshoot, and maintain equipment for engineering evaluations and Design Verification testing.
• Own the Design Verification laboratory infrastructure, including testing equipment, fixtures, software, environmental monitoring, preventive maintenance, calibration schedules, and laboratory readiness for engineering development and formal verification testing.
• Install, qualify, calibrate, maintain, repair, and document laboratory equipment.
• Coordinate preventive maintenance and vendor service.
• Prepare SOPs, work instructions, equipment records, DV documentation, calibration logs, and maintain compliance with FDA Design Controls, 21 CFR Part 820/QMSR, ISO 13485, and company QMS.
• Manage laboratory inventory, engineering supplies, prototype components, purchasing requests, receiving inspection, shipment of prototypes and test articles, and inventory accuracy.
• Maintain prototype inventory, traceability, labeling, storage, configuration control, and engineering build support.
• Train technicians, promote laboratory safety, implement 5S/Lean improvements, and recommend workflow enhancements.

Skills

Laboratory instrumentation

Documentation

Inventory management

Microsoft Office

Mechanical aptitude

Regulated environments

Design Verification testing

Education

Associate's or Bachelor's in Engineering Technology / Biomedical Engineering / Mechanical Engineering Technology

Tools

DV testing equipment

Calibration tools

Environmental monitoring software

Job description

MicroPort Endovastec MedTech Inc. of Irvine, California, is a medical device company focused on endovascular devices.

The Lead Engineering Laboratory Technician leads daily R&D lab operations, supports design verification testing, and ensures compliance with FDA and ISO 13485 quality systems. You will own laboratory infrastructure, manage equipment, calibration, documentation, and prototype control while coordinating a safe, efficient lab and supporting multiple engineering projects in a