Senior Engineer, Product Transfer
hace 3 semanas
**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.
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