Manufacturing Engineer-Hands On-Robotics
Responsibilities:
- Provide hands-on engineering support, trouble-shooting and maintenance of robotic and automated HMLV production floor equipment in 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 focus on root cause(s). Lead and assist with defining and implementing corrective and preventive actions, and resolution to audit findings.
- Prepare, complete and support validations (IQ/OQ/PQ) to meet applicable FDA and regulatory requirements.
Qualifications:
- Bachelor Degree in Mechanical, Electrical, Robotics, Automation, or other relevant Engineering & Technology disciplines with 5+ years of experience, or equivalent combination of education and experience.
- Prior hands-on working experience with Robotics & Automation, PLCs, HMIs, Vision Systems, Servos, and Labelers desired
- Strong technical, project management and documentation skills desired
- Prior experience in working with and managing suppliers and/or subcontractors desired
- Self-starter, highly organized, complex problem solver with technical, detail-oriented mindset and strong analytical and communication skills desired
- Demonstrated ability to work in a highly regulated environment desired
- Knowledge of FDA QSR requirements, ISO 13485, or other recognized international quality system standards desired
- Prior experience maintaining robotic & automated equipment desired
- Prior experience with process/equipment validation: documentation and execution - IQ, OQ, PQ desired
- Experience with DI water systems, cold room management, central monitoring systems preferred
- Experience with FMEA, DOE, SPC preferred
- CAD, SolidWorks experience preferred
- Experience with SAP, Oracle, Agile and Electronic Batch Records preferred
- Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, Sato and DataMax Labelers preferred
- Knowledge of Industry 4.0, AI, predictive analytics and touchless transactions bonus
Volt is an Equal Opportunity Employer