Robotics Automation Engineer
Santa Barbara, CA
90-115K + Bonus + Relocation + Full Benefits
In the Diagnostics and Genomics Group (DGG), our Manufacturing Engineering team partners very closely with other functions in the Order Fulfillment and Supply Chain (OFS) to support the manufacture of highly regulated medical devices which are critical for physicians to help select therapies for their patients.
Become a part of a growing and dedicated engineering team that does essential work in support of Finished Production. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
Reporting to the Engineering Manager, you will be an integral part of a cross-functional team of engineers and technicians growing in size and responsibilities as the business needs increase.
In this visible and diverse role, you will provide hands-on production equipment support, trouble-shooting, repairing and maintaining essential robotics and automation machinery. You will manage capital equipment and improvements projects, as well as work closely with vendors and contractors. You will also partner with QA on preparing and approving validation and other documents and procedures essential for regulatory compliance.
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.
Required Knowledge, Skills & Abilities
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
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 Knowledge, Skills & Abilities
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 experience
Experience with SAP, Agile, and Electronic Batch Records
Prior hands-on experience with programming Fanuc and Denso robots, Omron and Allen Bradly PLC, HMIs, Cognex Vision Systems, Zebra, Sato and DataMax Labelers
Knowledge of Industry 4.0, AI, predictive analytics and touchless transactions
Robotics & Automation
Project Management – Capital Equipment
1. 5+ years exp. with Robotics & Automation – Hands on experience working with automated manufacturing equipment
2. Project management experience (Capital Equipment) replacing aging equipment
3. Validation experience ISO Documentation experience (can train on this but must be willing to be trained on it)
4. Continuous improvement/Digitalization
o Process Improvements
Benefits include: Medical, Dental, Vision, 401K w/employer matching, generous paid time off and paid volunteer time off, work/life balance, positive company culture, opportunities for growth & development.
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