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Mechanical Engineer

2 months ago

Carpinteria, California, United States Agilent Full time
About the Role

As a Mechanical Engineer at Agilent Technologies, you will be part of a dynamic team that is shaping the future of Precision Medicine. Our mission is to improve human health by bringing cutting-edge technology to labs, partners, and patients worldwide.

Job Summary

We are seeking a highly skilled Mechanical Engineer to join our Diagnostics and Genomics Group (DGG). In this role, you will partner closely with cross-functional teams to support the manufacture of highly regulated medical devices. Your expertise will be essential in providing hands-on production equipment support, troubleshooting, and maintenance of robotic and automated machinery.

Key Responsibilities
  • Provide hands-on engineering support, troubleshooting, and maintenance of robotic and automated HMLV production floor equipment in a regulated environment.
  • Define, procure, and support robotic and automated filling, labeling, and packaging equipment (SOW, Functional Spec., FAT, SAT).
  • Apply Project Management skills and tools to lead and support capital equipment and improvement projects.
  • Resolve equipment failures with a focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions (CAPA), and resolution to audit findings (NCR, SCAR, etc.).
  • Prepare, complete, and support validations (IQ/OQ/PQ/SQ) to meet applicable FDA and regulatory requirements.
  • Support continuous improvement initiatives to enhance product quality and reduce manufacturing costs.
Requirements
  • Bachelor's Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 4+ years of experience, or equivalent combination of education and experience.
  • Prior hands-on working experience with Automation and Robotics, PLCs, HMIs.
  • Prior experience maintaining robotic & automated equipment.
  • Prior experience with process/equipment validation: writing documentation and execution - IQ, OQ, PQ.
  • Strong technical, project management, and documentation skills.
  • Self-starter, highly organized, complex problem solver with technical, detail-oriented mindset and strong analytical and communication skills.
  • Demonstrated ability to work in a regulated environment.
Preferred Qualifications
  • Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards.
  • Prior experience in working with and/or managing suppliers and/or subcontractors.
  • Experience with DI water systems, cold room management, central monitoring systems.
  • Experience with FMEA, DOE, SPC.
  • CAD, SolidWorks, Siemens NX experience.
  • Experience with SAP, Agile, Electronic Batch Records (EBR) or Manufacturing Execution Systems (MES), and SCADA.
  • Prior hands-on experience with programming Fanuc and Denso robots, Omron, Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, and Sato Labelers.
  • Knowledge of Industry 4.0, AI, predictive analytics, Machine Learning, Data Science, and touchless transactions.