Job Description

Job Description

Description

Job Title: Manufacturing Engineer

Location: On Site - Iselin, New Jersey, United States

Salary: $80,000 - $110,000

Skills: CAD, SolidWorks, Tooling, Fixtures, Process Improvement

About the Machinery Manufacturing Company / The Opportunity:

Our client, a dynamic company in the machinery manufacturing industry, is seeking a Manufacturing Engineer to join their team in Iselin, New Jersey. This is an exciting opportunity to contribute to the design and improvement of manufacturing processes, tooling, and fixtures while ensuring high product quality and production efficiency. The role offers the chance to work in a regulated environment, focusing on cleanroom operations, process validation, and cross-functional collaboration. If you are a motivated professional looking to make an impact, this opportunity is perfect for you.

• Responsibilities: Design, develop, and enhance manufacturing processes, tooling, and fixtures.
• Evaluate and maintain production equipment to ensure optimal performance.
• Support production operations, including conducting process validations.
• Collaborate with vendors for incoming components and ensure quality standards.
• Troubleshoot and resolve manufacturing process and equipment issues.
• Apply statistical tools such as Gage R&R, Cp, Cpk, and SPC to optimize processes.
• Implement manufacturing concepts like Value Stream Mapping, 5S, and Visual Workplace.
• Prepare and maintain protocols, reports, and process documentation.
• Work with cross-functional teams to drive process improvements and innovation.
• Ensure compliance with FDA regulations, QMS standards, and company policies.

• Must-Have Skills: Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical, or Manufacturing Engineering, or equivalent experience.
• 3–5 years of engineering experience in medical device manufacturing or a similar regulated industry.
• Experience with cleanroom operations, process validation, and handling production materials/chemicals.
• Proficiency in Microsoft Word and Excel, with experience in SolidWorks, Minitab, and CAD.
• Strong organizational, problem-solving, and communication skills.

• Nice-to-Have Skills: Experience in FDA-regulated environments and familiarity with QMS standards.
• Knowledge of advanced manufacturing methods and techniques.
• Experience with statistical process control and data analysis tools.
• Ability to work independently and collaboratively in a fast-paced environment.
• Hands-on experience with lean manufacturing concepts and methodologies.

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