Manufacturing Engineer II

Vantedge Medical•San Jose, CA

5h•$115,250 - $124,600•Onsite

About The Position

We are seeking a process oriented and results-driven Manufacturing Engineer II to lead process development and improvement in a medical device and data center industry contract manufacturing environment at our Stockton, California site. The primary responsibility of this position is to apply engineering principles to drive process improvements in manufacturing to positively affect Quality, Delivery, Cost, Safety and Morale. We’re looking for someone with a positive attitude and attention to detail who wants to grow professionally with high internal expectations. This role supports base business improvement and/or new product launches, develops tooling and fixtures, implements lean methodology, investigates issues using root cause analysis, implements improvements, manages CAPAs, and creates documentation such as standard work and validation protocols. The engineer collaborates cross-functionally to optimize designs for manufacturability and cost and communicates effectively with internal teams and customers.

Requirements

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
Lean manufacturing and new product development or launch support experience is highly desirable.
Understanding of sheet metal fabrication, processing, and polishing is strongly preferred.
Ability to work in a team environment.
Strong written and oral communication skills.
Experience in medical devices is preferred.
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

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.
Plan and execute projects, with minimum supervision, on time and within budget to achieve tangible results.
Drive improvements through root cause analysis and data driven decision-making.
Participates in cross-functional project teams to implement creative solutions.
Ensure internal and external customer expectations are met or exceeded.