Job Description

Job Description

Job Title: Manufacturing Engineer II

Company: Intellectt Inc.

Location: Avon, IN

Job Description

We are seeking a Manufacturing Engineer II to support manufacturing processes, equipment qualification, quality systems, engineering documentation, and continuous improvement initiatives within a regulated medical device manufacturing environment.

Job Responsibilities

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• Develop and execute technical activities to improve existing products, manufacturing processes, and equipment.
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• Manage Quality Management System (QMS) documentation and ensure compliance with applicable company procedures and quality requirements.
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• Author and manage engineering change orders, including work instruction updates and document revisions using Windchill.
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• Lead installation qualifications and develop and execute installation qualification protocols.
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• Own equipment and process documentation, including equipment qualification and non-product software validation.
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• Support temperature mapping, validation activities, and maintenance of qualification records.
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• Provide manufacturing floor and operations support, troubleshoot equipment and process issues, and coordinate corrective actions.
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• Support robotics, production printers, and other manufacturing equipment.
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• Coordinate maintenance, calibration, and preventive maintenance activities.
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• Manage incoming material setup, repack setup, packaging setup, and master data maintenance.
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• Prepare technical reports, presentations, and monthly business review metrics.
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• Coordinate with vendors and cross-functional teams on engineering, manufacturing, quality, and project activities.
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• Maintain accurate documentation and ensure compliance with applicable quality systems and business procedures.
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• Apply engineering principles and problem-solving techniques to improve manufacturing performance and process reliability.
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Required Qualifications

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• Bachelor's degree in Science or Engineering, preferably Electrical, Software, Mechanical, or a related engineering discipline.
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• 3–5 years of relevant engineering experience.
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• Experience managing Quality Management Systems (QMS).
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• Experience authoring engineering change orders and preparing technical documentation.
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• Experience leading installation qualifications and developing installation protocols.
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• Strong technical writing, analytical, troubleshooting, and problem-solving skills.
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• Ability to coordinate cross-functional projects and manage multiple priorities.
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• Strong communication and documentation skills.
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Preferred Qualifications

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• Lean Six Sigma Green Belt or Black Belt certification.
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• Experience with Windchill change management and work instructions.
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• Experience with equipment and process qualification, non-product software validation, and temperature mapping.
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• Familiarity with manufacturing operations, equipment maintenance, calibration, and preventive maintenance.
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• Experience in medical device manufacturing or another regulated manufacturing environment.
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Pay Scale : Approximately $40-42/Hr on w2 (Negotiable based on the experience)

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

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