Hologic

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R&D Engineer 2 CR (Temporary 12 months)

Job Title / Nombre del puesto: R&D Verification and Validation Engineer 2
Department / Departamento: R&D
Position Reports to / La posición reporta a: Sr Manager R&D Sustaining Engineering/Manager, R&D Sustaining Engineering/Manager, R&D Engineering / R&D V&V Superintendent / Director, R&D, Continuous Product Improvement
Organizational Relationships / Relaciones dentro de la organización: All Departments

Quality Responsibility (Authority) / Responsabilidad sobre la Calidad (Autoridad)

Place an "X" in the box / Coloque una “X” en la casilla
Assess / Evaluar Perform / Ejecutar Manage / Gerenciar

  • Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

    The R&D Verification and Validation Engineer 2 performs a variety of duties that require creativity and innovation.

    Supports research, design and development projects including creating tooling and fixtures to meet product requirements and user needs.

    Assume technical role on a cross-functional team on new products, design changes, process changes, design for manufacturability, and product enhancements including related testing, tooling, and fixtures related to the design validation and verification activities.

    Support and provide feedback to new products by troubleshooting product, process, and component issues.

    Lead the solution development to design, process, and quality issues through the application of engineering principles, analysis, and empirical methods.

    Create and maintain accurate documentation per Quality System of prototype concepts, drawings, fixtures, test methods, procedures, and reports.

    Define and create prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.

    Propose designs of prototype fixtures and establish methods to execute design verification activities.

    Develop test methods, generate protocols, and complete reports for design verification, and design validation.

    Execute Protocols and laboratory notebook studies and engineering studies.

    Support in modeling components and assemblies in CAD and create detailed drawings.

    Coordinate work with outside vendors/laboratories and internal personnel including material procurement and testing.

    Support completion of Design History File Documentation per FDA requirements.

    Per management strategic decisions, work closely to the PMQA personnel to aid and support activities in the Post Market Surveillance Laboratory. Aid and support of activities could comprise, but not limited to develop, control, and analyze metrics implemented; create new or modify implemented process, perform root cause investigation, and root cause assessments.

  • Qualifications / Cualificaciones:

    Customer Focus

    Problem Solving

    Informing

    Drive For Results    

  • Education / Educación: University level: A Bachelor of Engineering degree. Equivalent: University diploma or technical certification at least 350 hours.

  • Experience / Experiencia: 2 years of experience in the related field in a medical device industry.

  • Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):

    Competency in statistical analysis and tools (MiniTab preferred)

    Strong knowledge of Test Method Validation

    Basic Knowledge of electromechanical systems

    Competency in measurements systems and metrology

    Proficiency using CAD tools (SolidWorks preferred)

    Familiar with Good Laboratory Practices and QSR (Quality Systems Regulations)

    Competency in Tolerance Stack up analysis of mechanical components.

  • Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible): Spanish/English

  • Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:

    Basic Skills in Microsoft Worda, Excel, Outlook, Power Point, and other office software programs.

    Basic knowledge using CAD tools (SolidWorks).

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