Automation Process Engineer – NPI Assembly Equipment Project
We are seeking an experienced Automation Process Engineer to support a key New Product Introduction (NPI) project involving the design, qualification, and integration of new automated assembly equipment for a combination medical device.
Responsibilities
- Lead and support the design, qualification, and integration of new automated assembly equipment.
- Perform electro-mechanical troubleshooting on high-precision automated systems.
- Collaborate cross-functionally with engineering, validation, quality, and manufacturing teams.
- Manage and support validation activities including IQ/OQ/PQ protocols.
- Drive equipment commissioning and process development for new production lines.
- Provide technical input on Ultrasonic welding of plastic parts and its integration in automation systems.
- Work with external vendors and internal stakeholders to ensure equipment meets AbbVie network standards.
- Participate in risk management, CAPA, and continuous improvement (CIP) initiatives.
- Report progress at various project milestones and present updates to project leadership.
Requirements
- Bachelor’s Degree in Engineering or a related technical discipline.
- Minimum 3 years’ experience in automation engineering within a medical device manufacturing environment.
- Proven track record in assembly automation, new line introductions (NPI), and validation.
- Experience with Ultrasonic welding of plastic components in an automated environment.
- Strong working knowledge of GMP, FDA, and ISO regulatory requirements.
- Excellent problem-solving, communication, and cross-functional team collaboration skills.
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