Senior Engineer, Product Transfer

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.