Manufacturing Engineer II

Vantedge Medical; San Jose (CA); On-site; USD 110,000 - 120,000; Full time

Job summary

Vantedge Medical in San Jose, CA is seeking a Manufacturing Engineer II to lead process development and drive product launches in a medical device contract manufacturing environment.

You will apply lean methods, contribute to cost reductions, and ensure compliance with ISO and FDA regulations while collaborating with cross-functional teams.

This on-site role demands strong problem solving, teamwork, and the ability to communicate with customers and suppliers.

Qualifications

• Bachelor's degree in engineering or technical field.
• 5+ years of experience in a similar role.
• Strong problem-solving and data analysis abilities.
• Experience with NPI and lean manufacturing.
• Knowledge of ISO and FDA regulations in medical device manufacturing.
• Ability to work in a team and communicate effectively.

Responsibilities

• Drive process development and new product launches.
• Lead lean initiatives to improve quality, delivery, and cost.
• Develop and validate manufacturing processes and documents.
• Collaborate with vendors, engineering, and production teams.
• Ensure compliance with FDA/ISO and safety requirements.

Skills

Lean Manufacturing

New Product Introduction

Process Improvement

GDT

Team Collaboration

Problem Solving

Microsoft Office

Education

Bachelor's Degree in Engineering

Tools

MS Office

Job description

Manufacturing Engineer II

Job Type & Salary: Full‑time | Permanent, Salaried | On‑Site. Salary: $110,000 - $120,000.
Location: San Jose, California.

About Us

Vantedge Medical is the premier metals‑based med‑tech solutions partner from concept to full‑scale manufacturing. We are at the forefront of precision engineering and innovation, specializing in the development and manufacturing of vital components for medical markets such as robotic assisted surgery, orthopedics, surgical instruments, dental, and more. Our teams work in unison, collaborating and problem‑solving to serve the manufacturing needs of the top medical original equipment manufacturers (OEMs) around the globe. Making a difference in the lives of patients and their families drives us to go above and beyond every day. With a steadfast commitment to advancing medical technology, we take immense pride in the work we do – and have a lot of fun doing it.

About This Opportunity

We are seeking a process‑oriented and results‑driven Manufacturing Engineer to lead 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.

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).
• Lead process improvement projects at the technical level including analyzing data, creating the problem statement, executing methodology, and outlining the benefits.
• 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.
• Infrequent travel as needed for customer meetings and industry events.

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.

Salary Description

$110,000 - $120,000.