Equipment Engineer 4

Job description

Primary Function of Position: Senior Equipment engineers ensure the efficient and reliable operation of manufacturing equipment used in the production of medical devices. This role involves designing, developing, and maintaining equipment and processes to meet high-quality standards and regulatory requirements. The Senior Equipment Engineer also leads validation activities, troubleshoots technical issues, and collaborates with cross-functional teams to support new product introductions and continuous improvement initiatives. Additionally, they provide technical expertise and mentorship to junior staff, ensuring the overall effectiveness and compliance of the manufacturing operations. Essential Job Duties: Design, develop, and implement equipment and processes for manufacturing medical devices. Lead and manage equipment validation activities, including IQ, OQ, and PQ protocols. Troubleshoot and resolve equipment-related issues to ensure minimal downtime and optimal performance. Collaborate with cross-functional teams to support new product introductions and process improvements. Develop and maintain detailed equipment documentation, including specifications, maintenance procedures, and calibration records. Ensure compliance with regulatory standards (e.g., FDA, ISO) and company quality policies. Provide technical guidance and mentorship to junior engineers and technicians. Conduct risk assessments and implement corrective and preventive actions (CAPA) for equipment-related issues. Manage equipment procurement, installation, and commissioning projects. Monitor and analyze equipment performance data to drive continuous improvement initiatives. Required Skills and Experience : Technical Expertise: Strong knowledge of equipment design, development, and validation processes, including IQ, OQ, and PQ protocols. Regulatory Knowledge: Familiarity with regulatory standards such as FDA, ISO 13485, and GMP requirements. Problem-Solving Skills: Proven ability to troubleshoot and resolve complex equipment-related issues. Project Management: Experience managing equipment procurement, installation, and commissioning projects. Documentation Skills: Proficiency in developing and maintaining detailed equipment documentation, including specifications, maintenance procedures, and calibration records. Analytical Skills: Ability to analyze equipment performance data and implement continuous improvement initiatives. Communication Skills: Strong verbal and written communication skills for effective collaboration with cross-functional teams and external vendors. Attention to Detail: High level of accuracy and attention to detail in all aspects of work.Strong communications skills across team organizations and cultures. Must be able to speak, read and write in English 80%. Must be able to travel to the USA. Required Education and Training: Bachelor’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related field (Required). Master’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, or a related field (Preferred). Working Conditions: None Preferred Skills and Experience: Experience: 7-10 years of experience in equipment engineering, with a significant portion in the medical device or pharmaceutical industry. Leadership: Experience providing technical guidance and mentorship to junior engineers and technicians. Software Proficiency: Familiarity with CAD software, PLC programming, and other relevant engineering tools. Mid/high volume complex mechanism manufacturing engineering experience preferred. Experienced in ISO 13485, or medical device manufacturing environment. Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables. Aviso sobre los Controles de Exportación de EE. UU.: De acuerdo con las Regulaciones de Administración de Exportaciones de EE. UU. (15 CFR §743.13(b)), algunos puestos en Intuitive Surgical pueden estar sujetos a controles de exportación de EE. UU. para candidatos que sean nacionales de países actualmente bajo embargo o sanciones. Cierta información que usted proporcione como parte de la solicitud será utilizada para determinar si Intuitive Surgical necesitará (i) obtener una licencia de exportación del gobierno de EE. UU. en su nombre (nota: el proceso de obtención de la licencia puede tardar entre 3 y más de 6 meses) o (ii) implementar un Plan de Control de Tecnología (“TCP”, por sus siglas en inglés) (nota: normalmente este paso agrega 2 semanas al proceso de contratación). Para cualquier puesto en Intuitive sujeto a controles de exportación, las ofertas finales están condicionadas a la obtención de una licencia de exportación aprobada y/o a la ejecución de un TCP antes de la fecha de inicio del empleado potencial, la cual puede o no ser flexible, y dentro de un plazo que no obstaculice de manera irrazonable la necesidad de contratación. Si aplica, los candidatos serán notificados e instruidos sobre cualquier requisito relacionado con estos fines. Este puesto puede cubrirse con un nivel de puesto diferente al indicado aquí, según las necesidades del negocio y/o la experiencia, los conocimientos y las habilidades del candidato o la candidata seleccionado. La compensación se basará principalmente en el nivel del puesto en el que se cubra el rol y en las cualificaciones del candidato o la candidata, de conformidad con la legislación aplicable. It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive . As a global leader in robotic-assisted surgery and minimally invasive care , our technologies—like the da Vinci surgical system and Ion —have transformed how care is delivered for millions of patients worldwide. We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life. If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare , you’ll find your purpose here.