Mfg Robotics & Automation Engineer (Santa Barbara, CA)
- Project Management
- Capital Equipment
- ISO Documentation
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.
Required Knowledge, Skills & Abilities
- 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.
Preferred 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
- 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