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**Company Overview**Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis.
The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers.
Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone.
The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.
**Position Overview**:This validation engineer is responsible for ensuring that products and/or processes meet quality and regulatory requirements, and that these requirements are assessed and evaluated per adequate protocols, reports and execution practices.
**Responsibilities/Functions**- Develops and implements validation and verification plans, protocols, and reports to ensure that manufacturing processes and equipment comply with process manufacturing needs, Outset requirements, applicable regulatory standards, and customer requirements.- Developing statistical analysis as needed (DOE, R&R, Cpk/Ppk, ANOVA).
Perform validation activities, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for equipment, components, and processes.- Closely works with the project manager/program manager/change trigger to define duration times, validation needs, resource allocation and execution requirements.- Collaborate with cross-functional teams, including product development, quality assurance, and regulatory affairs, to ensure that validation activities or results are aligned with project timelines and goals.- Conduct risk assessments to identify potential risks and hazards associated with equipment, processes, or products and develop mitigation strategies.- Analyze data and prepare validation reports to document results and conclusions.- Troubleshoot issues related to equipment or processes during validation activities and work with technical teams to resolve problems.- Participate in continuous improvement activities to enhance the effectiveness and efficiency of validation processes.- Stay current with industry trends and regulatory requirements related to validation activities.- Train and mentor junior engineers and technicians on validation processes and procedures.- Maintain accurate and up-to-date validation documentation and ensure compliance with relevant regulations and standards.- Coordinate and execute as needed with cross-functional teams: process documentation and implementation activities