Validation Engineer

hace 5 meses

Tijuana, México Outset Medical A tiempo completo

**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.
- Release/Update process/equipment/product documentation (MPIs, Visual Aids, Preventive Maintenance procedures, pFMEAs, etc.)
- Participate in non-conformance report activities related to process validation activities, as needed.
- Own the change assessment for the implementation (CAF).
- When validating new or alternate components, follows on the procurement of the parts, coordinates the IQA activities and completes the applicable FAI sections, fit check, etc.

**Required Qualifications**
- Bachelor's degree required in mechanical, electrical, or other related engineering disciplines.
- 5 - 7 years of experience in a related field.
- Strong technical skills, including knowledge of validation requirements, statistical analysis.
- Experience in the use of Minitab.
- Thorough understanding of relevant regulations and standards, such as FDA, ISO, and GMP requirements.
- Ability to work effectively in a fast paced and dynamic environment.
- Familiar with main failure mechanisms in electromechanical and fluidic system.
- Leadership and interpersonal skills to develop and manage good working relationships with cross functional teams.
- Strong attention to detail to ensure validation plans, protocol and reports are accurate and complete.
- Strong written and verbal communication skills (English and Spanish)
- Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
- Ability to exercise independent judgment.
- Proficient on basic computer programs: Microsoft Excel, Word, PowerPoint, Project
- Proven ability to handle multiple projects and meet deadlines.

Privacy is important to us. Please review our **Applicant Privacy Notice.**

**EQUAL EMPLOYMENT OPPORTUNITY STATEMENT**

Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender ide

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