Engineer II, Supplier Quality

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems / procedures to optimize product development, internal and external device manufacturing, and device distribution.

How you'll make an impact :

• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Develop moderately complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes / methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design / design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
• Develop, update, and maintain technical content of risk management files
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
• Other incidental duties assigned by Leadership

What you'll need (Required) : Education and experience requirements

Bachelor's degree in engineering or Scientific field, minimum 2 years of experience Required or

Master's Degree or equivalent internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry / education Required

What else we look for (Preferred) : Relevant skills