What are the responsibilities and job description for the Quality Engineer II, New Product Development position at Edwards Lifesciences?
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.
This Quality Engineer II will support a Metals project through the development phase and into manufacturing production. They will contribute to process development and execution of design verification and validation activities as well as support the transition of the project to manufacturing and stabilize the line through knowledge of lean principles, root cause investigations, and driving yield improvement. In addition, they will support supplier and receiving inspection related activities.
How you'll make an impact :
- 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
- Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production
- 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
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Other incidental duties assigned by Leadership
What you'll need (Required) :
What else we look for (Preferred) :
Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
