**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.
