Senior Product Development Engineer

hace 7 días

Tijuana, Baja California, México Stryker Corporation A tiempo completo
About the Role

We are seeking a highly skilled Senior Product Development Engineer to join our team at Stryker Corporation. As a key member of our engineering team, you will be responsible for executing engineering activities for product transfers and new product introductions.

Key Responsibilities
  • 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.
Requirements
  • Bachelor's degree in an engineering discipline.
  • Six Sigma Yellow belt or higher certification.
  • Valgenesis or other related validation control software certification.
  • 4+ years of experience as Sr. Engineer on new product introduction or product transfer roles.
  • Experience at a highly regulated industry such as Automotive, Aerospace, or Medical device.
Preferred Qualifications
  • Demonstrated experience with Microsoft products - Excel, Access, PowerPoint, MS Project.
  • 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.

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