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Senior Engineer, Product Transfer
hace 3 meses
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.
- 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
- Bachelors 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 Automotive, Aerospace or Medical device
- 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
