Vantedge Medical ยท 9 hours ago
Manufacturing Engineer II
Stockton, CA
Full-time
Onsite
Senior Level
$90K/yr - $105K/yr
5+ years expVantedge Medical is a premier metals-based med-tech solutions partner dedicated to advancing technology in the medical device and data center industries. The Manufacturing Engineer II will lead process development and improvement initiatives, applying engineering principles to enhance manufacturing quality, delivery, cost, safety, and morale.
ManufacturingMedicalMedical Device
Responsibilities
Adheres to all safety and quality requirements including but not limited to: Quality Systems, U.S. Food and Drug Administration (FDA) regulations, ISO, company policies and operating procedures, and other regulatory requirements
Creates and implements lean processes in a cellular environment utilizing appropriate methods such as metals machining, sheet metal fabrication, and sub-processing such as assembly, powder coat, and metal finishing, welding, laser cutting, and electrical harness assembly
Performs root cause analysis to identify and implement needed process improvements eliminating waste
Defines, produces and implements documents including standard work and process work instructions
Identifies, develops, justifies, and executes detailed project plans for engineering work with minimum supervision
Ability to launch new products effectively in a contract manufacturing environment
Investigates, develops and implements new process technologies
Successfully communicates complex issues with customers and internal team members
Creates, reviews and approves engineering drawings, equipment layouts, change orders and specifications
Develops tooling, fixtures and equipment used in manufacturing to optimize productivity and cost
Effectively owns and manages CAPAs pertaining to their areas of responsibility
Collaborates with development, programmers, machinists and suppliers to evaluate designs for manufacturability and cost reduction
Creates and executes validation protocols, processes and material evaluations
Qualification
Required
Engineering or bachelor's degree in a technical field
5+ years of work experience in similar technical roles including medical device manufacturing required
Strong problem-solving skills
Ability to provide solid rational and justification for process improvement change requests
Ability to work in a team environment
Strong written and oral communication skills
Proficiency in Microsoft Office Suite
Working knowledge of ISO and FDA regulations and GD&T
Infrequent travel as needed for customer meetings and industry events
Preferred
Lean manufacturing and new product development or launch support experience is highly desirable
Understanding of sheet metal fabrication, processing, and polishing is strongly preferred
Experience in medical devices is preferred
Company
Vantedge Medical
Vantedge Medical offers medical equipment manufacturing services.
1001-5000 employees