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.