Lead Medical Device Engineering Laboratory Technician

Company Overview
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.
Website: www.endovastec.com/en
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.
Essential Responsibilities
Laboratory Operations
Coordinate daily laboratory operations and maintain a safe, organized, efficient laboratory.
Support multiple engineering projects and improve laboratory workflow.
Engineering & Design Verification Support
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.
Vendor Coordination
Coordinate external service providers, equipment installation, calibration, and procurement activities.
Leadership & Continuous Improvement
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.

Work arrangement
No