Senior Engineer, Product Transfer

hace 1 semana

Tijuana, México Stryker A tiempo completo
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Who We Want

  • Strategic thinkers. People who enjoy analyzing data or trends for planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • 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.
  • Motivated product launchers. People who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

What You Will Do

  • Execute engineering activities for product transfers and/or new product and process introductions within the designated project, ensuring compliance with Stryker procedures and thorough documentation of all activities.
  • Ensure the quality of processes and products as defined in the appropriate operation and material specifications specific to the project.
  • Assist in the selection of components and equipment based on analysis of specifications, reliability, safety, and regulatory requirements relevant to the project.
  • Participate in or support capital acquisition activities within the project scope, including specifying equipment, installation, and validation.
  • Analyze equipment to establish operating data, conduct experimental tests, and analyze results, participating in process review meetings related to the project.
  • Capable of generating PFMEA, Control Plans, Work instructions, and relevant manufacturing documents specific to the project.
  • Generate PPAP associated with product transfers and launches within the project framework.
  • Perform process capability studies specific to the project requirements.
  • Generate in-process and subsequent inspection documentation within the context of the project.
  • Conduct MSA studies for new products and new processes within the project parameters.
  • Provide training for manufacturing team members within the project scope
  • Ensure adherence to GMP and safety procedures within the project framework.
  • Interact with global teams as necessary to support project objectives
  • Capable of presenting to local management level within the project scope
  • Perform all other duties as assigned within the context of the project

Education Level And Special Training Required

  • Bachelors degree in an engineering discipline
  • Six Sigma Yellow belt or higher certification
  • Valgenesis or other related validation control software certification

Work Experience Required

  • 4+ years of experience as Sr. Engineer on new product introduction or product transfer roles
  • Experience at a highly regulated industry such Automotive, Aerospace or Medical device

Qualification And Skills

  • Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project required
  • Bilingual: English & Spanish
  • Demonstrated Leadership, Project Management and Engineering experience in New Product Introduction in a regulated environment
  • Experience in an FDA regulated or regulated industry
  • Experience of GD&T, process mapping, statistical methods and process/product validations
  • Experience in executing/reporting EQ, OQ, PQ
  • Change management experience with regulated system
  • Develop Work instructions
  • Experience with DOE
  • Experience on DFM
  • 2D CAD skills
  • Minitab
  • Internal PPAP
  • Capable to develop MVP
  • SAP - master data
  • Experience with MES
  • Fixture design/proposal with Poka Yoke
  • Root cause analysis techniques
  • Layout Design
  • Value stream mapping

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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