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Manufacturing Engineer

$35 - $40 per hour

Medical Devices and Supplies

Manufacturing Engineer II Pay Range: $35/hr to $40/hr Location: Avon, IN 46123 Work Type: Onsite Contract Duration: 12 Months, with possible extension based on performance and business needs Job Summary: We are seeking a hands on Manufacturing Engineer II to support manufacturing operations, equipment qualification, process validation, and quality system effectiveness in a regulated manufacturing environment. The ideal candidate will have experience in technical writing, quality management systems, engineering change control, and installation qualification activities. This role requires ownership of equipment and process documentation, validation protocols, and work instruction updates. The engineer will troubleshoot operational challenges, coordinate with vendors, and support manufacturing equipment, robotics, printers, and material handling processes. Strong project management, communication, and mentoring skills are essential to drive technical initiatives and continuous improvement. Key Responsibilities: Develop, review, and maintain technical documentation, work instructions, engineering change orders, and equipment and process documentation using Windchill or similar product lifecycle management systems. Lead installation qualification activities and prepare, execute, and maintain installation qualification protocols and related validation documentation. Own equipment qualification, nonproduct software validation, and temperature mapping activities in accordance with established quality system requirements. Support material setup, repackaging setup, packaging setup, and master data maintenance to ensure manufacturing readiness and operational accuracy. Provide hands on floor support and troubleshoot manufacturing operations, robotics, printers, and other production equipment to resolve technical issues. Coordinate maintenance, calibration, and preventive maintenance activities to support equipment reliability and compliance. Prepare monthly business review reports, track performance metrics, and communicate project progress, findings, and recommendations to stakeholders. Coordinate with internal teams and external vendors to support engineering projects and operational initiatives. Update work instructions and technical documentation to reflect current manufacturing processes and approved changes. Provide technical guidance, coaching, and mentoring to engineers, operations personnel, and other team members while collaborating across functions. Drive assigned projects to completion by managing priorities, addressing issues, and advocating for site requirements and operational objectives. Required Qualifications: Bachelor of Science or Bachelor of Engineering degree in Electrical Engineering, Software Engineering, Mechanical Engineering, or a related engineering discipline. Three to five years of relevant engineering experience in manufacturing, process engineering, equipment engineering, or a related technical environment. Hands on experience with quality management systems and engineering change order authoring. Demonstrated experience in technical writing, equipment and process documentation, and work instruction development. Experience leading installation qualification activities and preparing or executing installation qualification protocols. Experience with equipment validation, process documentation, or nonproduct software qualification. Strong troubleshooting, project coordination, communication, and organizational skills. Ability to work onsite in Avon, Indiana, and provide hands on manufacturing floor support. Preferred Qualifications: Lean Six Sigma Green Belt or Black Belt certification. Experience with Windchill or similar product lifecycle management and document change management systems. Experience with temperature mapping, equipment calibration, and preventive maintenance programs. Experience supporting robotics, manufacturing printers, packaging operations, and material setup. Experience with master data maintenance, operational metrics, and monthly business review reporting. Demonstrated ability to mentor peers, coach operations teams, and coordinate with internal and external stakeholders. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable

Vacancy posted 4 days ago
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