Lead Medical Device Engineering Laboratory Technician

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. is a medical device company based in Irvine, California, focused on the research, development, and manufacturing of aortic and peripheral vascular interventional devices. Established in 2022, the company is a wholly owned U.S. subsidiary of Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd. (Endovastec), a global medical technology company headquartered in Shanghai, China.

Endovastec's global business spans aortic, peripheral vascular, and tumor intervention devices. Its portfolio includes thoracic and abdominal aortic stent grafts, peripheral vascular stents, and balloon catheters. Our Irvine R&D team supports the development of endovascular aortic stent graft systems through prototype development, engineering evaluations, and design verification testing, contributing to technologies designed to improve treatment options for patients with vascular disease.

Position Summary

The Lead Engineering Laboratory Technician is responsible for leading day-to-day R&D laboratory operations supporting the development of endovascular aortic stent graft systems. The role provides hands-on technical leadership in laboratory operations, design verification support, equipment lifecycle management, documentation, prototype control, inventory, logistics, and compliance with FDA and ISO 13485 quality system requirements.

Laboratory Operations

• 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 (DV) testing.
• Build test fixtures, execute test protocols, collect data, support prototype assembly, and assist root cause investigations.

Design Verification Laboratory Ownership

• 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.

Equipment Management

• Install, qualify, calibrate, maintain, repair, and document laboratory equipment.
• Coordinate preventive maintenance and vendor service.

Documentation & Quality

• 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.

Inventory & Logistics

• Manage laboratory inventory, engineering supplies, prototype components, purchasing requests, receiving inspection, shipment of prototypes and test articles, and inventory accuracy.

Prototype & Configuration Management

• Maintain prototype inventory, traceability, labeling, storage, configuration control, and engineering build support.
• Coordinate external service providers, equipment installation, calibration, and procurement activities.
• Train technicians, promote laboratory safety, implement 5S/Lean improvements, and recommend workflow enhancements.

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.

Personal Attributes

Highly organized, detail-oriented, hands-on, self-motivated, collaborative, excellent communication skills, and able to manage multiple priorities in a fast-paced R&D; environment.

Physical Requirements

Ability to lift up to 30 lbs., stand for extended periods, and perform precision assembly and laboratory work.