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    Senior Engineer, Product Transfer - Tijuana, México - Stryker

    Stryker
    Stryker Tijuana, México

    hace 17 horas

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    De jornada completa
    Descripción

    Who we want

  • Strategic thinkers. People who enjoy analyzing data or trends for planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvements across the business.
  • Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

    • What you will do

  • Provide engineering support for new product and process introductions, ensuring that all activities are completed and documented in accordance with the Stryker new product development procedures.
  • Ensure quality of process and product as defined in the appropriate operation and material specifications.
  • Will assist in the selection of components and equipment based on analysis of specifications, reliability and regulatory requirements.
  • Support capital acquisition activities.
  • Will analyse equipment to establish operating data, conduct experimental test and result analysis. Participate in process review meetings.
  • Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers and launches.
  • Complete capability studies for in process inspection and generate subsequent Inspection documentation.
  • Conduct MSA studies for new products and new processes.
  • Provide training for manufacturing team members.
  • Ensure adherence to GMP and safety procedures.
  • All other duties as assigned.

    • What you need

  • Bachelor's degree in an Engineering discipline.
  • 5+ years of experience in a FDA regulated industry, preferably Medical Devices.
  • Experience in Product Transfer and Validations (IQ, OQ, PQ).
  • Experience with Engineering changes and implementations.
  • Knowledge of quality processes and statistical analysis.
  • Excellent communication and interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams.
  • Excellent analytical skills, ability to plan, organize and implement concurrent tasks.
  • Bilingual: English & Spanish.
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