Computer System Validation Engineer

hace 2 semanas


Tijuana, México Corza Medical Tijuana A tiempo completo

Descripción y detalle de las actividades

What you will do As the Computer System Validation (CSV) Engineer you will: - Develop Computer Systems validation test strategy, test plans, test automation scripts, and test procedures to meet requirements. - Develops, and executes/coordinates protocols and test scrip, identify gaps, consult on and direct plans for resolution through constant communication with key stakeholders. - Be responsible for providing all documentation required to support the Computer System Life Cycle. This includes but is not limited to User Requirements, Functional Specification. operating instructions, electrical schematics, specifications, parameter settings, software and PLC’s backups etc. - Create and provide computer system specifications to vendors in collaboration with the appropriate departments ((R&D, Engineering, QA/RA, Supply Chain and Operations) i.e. User Requirements Specifications (URS) - Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues - Help, establish and sustain computer system validation global policies and standards that incorporate industry best practices and are health authority compliant. Act as a Quality liaison within project teams, guiding quality measures throughout the software development lifecycle and overseeing quality-related documentation. - Integrate quality practices into software development, scientific computation, and data acquisition processes. - Evaluate and approve software project deliverables, ensuring compliance with procedural standards. - Conduct risk assessments, manage risk mitigation activities, document product risks, and liaise with the risk management team for updates. - Maintain adherence to company's quality processes in software development and risk management efforts

Experiência y requisitos

**Número de vacantes** 2

**Área** Ingeniería

**Contrato** Permanente

**Modalidad** Presencial

**Turno** Diurno

**Jornada** Tiempo Completo

**Horario** L / V

**Estudios** Carrera Profesional

**Sexo** Indistinto

**Disponibilidad p. viajar** No


  • Validation Engineer

    hace 4 días


    Tijuana, Baja California, México BEPC Inc A tiempo completo

    1 to 3 years experience in Medical devices as engineer. Validation protocols execution experience IQ, OQ, PQ. Knowledge in statistics Write/Execute Change Management/Change Control Assessments (e. g. Validation, Process etc.). Create/Execute Engineering Changes Orders. Write/Approve changes related to manufacturing documentation such as Manufacturing Work...

  • Validation Engineer

    hace 2 meses


    Tijuana, México BEPC Inc A tiempo completo

    1 to 3 years experience in Medical devices as engineer. - Validation protocols execution experience IQ, OQ, PQ. - Knowledge in statistics - Write/Execute Change Management/Change Control Assessments (e. g. Validation, Process etc.). Create/Execute Engineering Changes Orders. Write/Approve changes related to manufacturing documentation such as Manufacturing...

  • Validation Engineer

    hace 2 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...


  • Tijuana, México North American Production Sharing A tiempo completo

    **Title: System Level Test** **Engineer, Senior** **Job Function**: Responsibilities for this position include working with engineering teams for early-stage silicon bring-up and post-silicon validation efforts, work with software teams to evaluate integrated system performance, test and characterize HW/SW interaction, Digital and RF device performance at...

  • Validation Engineer

    hace 4 días


    Tijuana, Baja California, México Outset Medical A tiempo completo

    Company OverviewOutset 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...


  • Tijuana, México North American Production Sharing de México A tiempo completo

    **Vacante para la empresa North American Production Sharing de México en Tijuana, Baja California**: **System Level Test Engineer** **Minimum Qualifications**: 1.2-6 years of hands-on silicon validation experience ranging across System/SW/ bench test/ HW-SW interactions, preferably in the mobile devices/microprocessor industry 2.Experience in analyzing...


  • Tijuana, Baja California, México OPTIMA ORGANIZATIONAL SOLUTIONS A tiempo completo

    Our client is a German global leading Medical devices manufacturer and they are looking for aSoftware Validation Engineer for their manufacturing facility in Tijuana, B.C. Design and develop test plans, procedures and generate test reports. Develop and execute automation scripts. Assist developers in debugging customer issues. Maintain/update defects...

  • Validation Engineer

    hace 2 meses


    Tijuana, México BEPC Inc A tiempo completo

    BEPC has a Tijuana area OPEN POSITION for **Validation Engineer I - II **to join our fast-growing team of consultants! This role will be working on the shop floor to define the impact of the variant part and components, directly working with associates, group leaders and supervisors. Responsible for Assessments, Process validations, Software validations,...


  • Tijuana, Baja California, México North American Production Sharing A tiempo completo

    Title: System Level Test Engineer, SeniorJob Function:Responsibilities for this position include working with engineering teams for early-stage silicon bring-up and post-silicon validation efforts, work with software teams to evaluate integrated system performance, test and characterize HW/SW interaction, Digital and RF device performance at various...


  • Tijuana, México OPTIMA ORGANIZATIONAL SOLUTIONS A tiempo completo

    Our client is a German global leading Medical devices manufacturer and they are looking for a **Software Validation Engineer** for their manufacturing facility in Tijuana, B.C. - Design and develop test plans, procedures and generate test reports. - Develop and execute automation scripts. - Assist developers in debugging customer issues. - Maintain/update...

  • System Engineer V&V

    hace 4 días


    Tijuana, Baja California, México Insulet Corporation A tiempo completo

    System Engineer V&V (Hybrid) page is loaded System Engineer V&V (Hybrid) Apply locations Aviacon, Tijuana time type Full time posted on Posted 3 Days Ago job requisition id REQ Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the...


  • Tijuana, México Bose A tiempo completo

    Job Description RESPONSIBILITIES - Design and develop test plans, procedures and generate test reports. - Develop and execute automation scripts. - Assist developers in debugging customer issues. - Maintain/update defects database with a defect tracking system. - Support determining root cause of defects through structured analysis - Manage validation...


  • Tijuana, Baja California, México Bose A tiempo completo

    Job DescriptionRESPONSIBILITIES Design and develop test plans, procedures and generate test reports. Develop and execute automation scripts. Assist developers in debugging customer issues. Maintain/update defects database with a defect tracking system. Support determining root cause of defects through structured analysis Manage validation schedules based on...

  • Validation Engineer

    hace 4 días


    Tijuana, Baja California, México Signify A tiempo completo

    Job TitleValidation Engineer - LED ElectronicsJob Description:We're looking for a strong Validation Engineer to join our LED Electronics R&D team in Tijuana, Mexico.Working for Signify means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and...


  • Tijuana, México Insulet Corporation A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...

  • System Engineer V&v

    hace 3 semanas


    Tijuana, México Insulet Corporation A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. - We...

  • System Engineer V&V

    hace 1 mes


    Tijuana, México Insulet A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are...

  • System Engineer V&V

    hace 1 mes


    Tijuana, Baja California, México Insulet A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...

  • System Engineer V&V

    hace 3 semanas


    Tijuana, Baja California, México Insulet A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...


  • Tijuana, México Insulet Corporation A tiempo completo

    Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.We are...