Easter Seals Jobs

MANUFACTURING ENGINEER

Summary

This position will focus on maintaining manufacturing equipment and processes to produce medical device products safely and efficiently meeting high quality standards. The position will be heavily involved in the day-to-day manufacturing needs to ensure equipment is running at optimal performance. This position will be responsible for developing, troubleshooting and modifying automated controls systems for manufacturing processes. This will include configuring and installing hardware components and writing and updating control logic programs. Data driven solutions for continuous improvement of existing and new processes will be a focus. To effectively perform there will be a mix of analytical planning and direct hands-on implementation and troubleshooting required.

Primary Responsibilities

• Ensure manufacturing equipment is running at optimal performance to meet safety, quality, and customer demand.
• Work independently and with project teams to establish and achieve continuous improvement goals for manufacturing.
• Preform analytical analysys to support and drive decisions needed to maintain current and future manufacturing process improvements.
• Develop, troubleshoot and modify automated controls systems for manufacturing processes
• Configure and install hardware components and write and update control logic programs using ladder logic
• Use electrical control schematics to troubleshoot manufacturing equipment control issues
• Distinguish between mechanical issues and controls related issues in equipment malfunctions
• Continuously Identify and address efficiency shortcomings and bottlenecks in manufacturing.
• Identify, secure, and implement updates to existing equipment and new equipment to support manufacturing in meeting demand.
• Lead efforts to meet 13485 quality requirements for process implementation and validation. (IQ, OQ, PQ)
• Lead efforts to do root cause analysis to identify improvement needs that address equipment efficiency and quality defect reduction.
• Ensures change management procedures are followed and changes are properly validated and documented per the quality system.
• Participate in maintaining manufacturing documentation for products, to include ERP system set up, component drawings and specifications, inspection plans, bill of material and routing, assembly and packaging drawings, standard operating procedures (SOPs), work instructions, quality plans, equipment validation documents (IQ/OQ/PQ) and other required documents. Ensures all documents are generated and in compliance with company quality system and customer requirements.

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``` - Participation in Internal and external quality audits - Define specifications for new and existing equipment. - Assess existing equipment to identify safety concerns and make recommendations for upgrades.

Education and Experience

• Bachelor's degree in Manufacturing , or Electro-Mechanical Engineering Disciplines preferred
• 2+ years of applied professional experience in process engineering or related manufacturing field.
• Medical Device manufacturing experience, with understanding of ISO13485:2016 preferred

Essential Knowledge, Skills and Abilities

Strong Electro-mechanical aptitude

Exceptional indirect leadership capabilities

Strong written and verbal communication skills

Effective project management skills

Detail oriented

Ability to select, implement, and troubleshoot electrical controls-based systems.

Ability to communicate with contractors to consult on control needs and requirements for process equipment.

Works well under pressure, effectively handles conflict, strict deadlines, and