Manufacturing Engineer

Radiant Systems Inc; Naperville (IL); On-site; USD 55,000 - 66,000; Full time

Job summary

Major Medical Device Client is seeking a Manufacturing Engineer in Naperville, IL, to optimize manufacturing processes and implement Six Sigma and Lean improvements. The role includes designing experiments, validating processes, and creating training materials for production teams.

You will analyze CAPA and audit findings, coordinate project plans, and guide technicians to ensure quality and efficiency in a fast-paced production environment.

Qualifications

• Bachelor's degree in Engineering required.
• Experience with Six Sigma and Lean methods preferred.
• Knowledge of FDA regulations for medical devices.
• Strong problem-solving, communication, and organizational skills.

Responsibilities

• Optimize manufacturing processes using Six Sigma and Lean methods.
• Develop experiments, run protocols, analyze results, and report findings.
• Analyze and resolve CAPA, non-conformances, and audit observations.
• Create work instructions and training materials for production.
• Plan projects to meet customer expectations using project management tools.
• Oversee technicians and coordinate tests; provide guidance and feedback.
• Perform other duties as assigned by Leadership.

Skills

Six Sigma

Lean methods

Project management

CAD

MS Office

Statistical analysis

Documentation

Manufacturing processes

FDA regulations

Education

Bachelor's degree in Engineering

Tools

MS Project

CAD

Job description

Client: Major Medical Device Client

Position: Manufacturing Engineer

Duration: 12+ months on W2

Pay Rate: $40.00-$48.00/ Hr on W2

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Job Description

Summary

The main function of a Manufacturing Engineer is to apply knowledge of technical principles and company systems/procedures to optimize manufacturing processes.

Job Responsibilities

• Optimize manufacturing processes, including using engineering methods (e.g., Six Sigma and Lean methods) for continuous process improvement and/or redesign/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills.
• Develop moderately complex experiments and tests, including writing and executing protocols, to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
• Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Develop training and documentation materials (e.g., work instructions) for production to enable seamless knowledge transfer of project and manufacturing processes.
• Establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Oversee manufacturing support tasks; provide instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Perform other incidental duties as assigned by Leadership.

Skills

• Good computer skills in the use of MS Office Suite, including MS Project; CAD experience preferred, if applicable.
• Good documentation, communication (written and verbal), and interpersonal relationship skills, including consultative and relationship management skills.
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment required, if applicable.
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical, and critical thinking skills.
• Solid understanding of processes and equipment used in assigned work.
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Knowledge of applicable FDA regulations for the medical device industry.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders.
• Ability to build productive internal/external working relationships.
• Adhere to all company rules and requirements, including Environmental Health & Safety rules, and take adequate control measures in preventing injuries to themselves and others, as well as protecting the environment and preventing pollution under their span of influence/control.

Education/Experience

• Bachelor's degree in Engineering required.