*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.