Manufacturing Engineer II

Vantedge Medical•San Jose, CA

6h•$110,000 - $120,000•Onsite

About The Position

We are seeking a process-oriented and results-driven Manufacturing Engineer to take the technical lead in process development, new product launches, and overall improvements in a medical device and data center industry contract manufacturing environment at our San Jose, California site. The primary responsibilities of this position are to apply engineering principles to drive activities that lead to successful product launches and improve overall 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. In this role, the Manufacturing Engineer is required to communicate effectively with customers as well as internal stakeholders.

Requirements

Bachelor’s Degree in an engineering or equivalent technical field.
5+ years of work experience in a similar technical role(s).
Demonstrated strong problem-solving skills and a go-to toolbox of techniques.
Ability to provide solid rationale and justification for process improvement changes.
Working level of Lean manufacturing knowledge and implementation.
New Product Introduction experience.
Understanding of metals fabrication, preferably sheet metal fabrication, processing (weld and finishing), and inspection.
Ability to work and collaborate in a team environment.
Ability to apply and interpret GD&T.
Strong written, presentation, and oral communication skills.
Experience in medical device manufacturing as a Contract Manufacturer.
Proficiency in Microsoft Office Suite.
Working knowledge of ISO and FDA regulations.
Infrequent travel as needed for customer meetings and industry events (<10%)

Responsibilities

Create and implement lean processes in a cellular environment that incorporate machining, sheet metal fabrication, and electro-mechanical assembly with associated sub- and outside-processing (e.g., powder coat, metal finishing, welding, laser cutting, and electrical harness assembly).
Complete launch readiness NPI deliverables associated within a manufacturing environment (i.e., design transfer).
Execute technical manufacturing activities including but not limited to MRB, CAPA, ECO approval & implementation, root cause analysis and effective corrective action countermeasure, deviation authorization, training, etc.
Define, produce and implement manufacturing documents including routings, standard work, method sheets, and process work instructions.
Develop tooling, fixtures and equipment used in manufacturing to optimize productivity and cost.
Create and execute validation protocols, processes and material evaluations.
Communicate and provide influence over complex issues with customers and internal stakeholders both face-to-face on site and remotely (e.g., TEAMS).
Investigate, develop, justify and implement new process technologies to reduce costs.
Collaborate with development, programmers, machinists and suppliers to evaluate designs for manufacturability and cost reduction.
Adhere 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.