Quality Engineer II - NPD

Edwards Lifesciences • Irvine, CA

1d • $87,000 - $123,000

About The Position

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. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. You will apply your 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 will make an impact: Support design assurance and development activities (i.e., requirement development, risk assessment, engineering study, feasibility testing, drawing review, etc.) for New Product Development program Participate in test method development/validation activities for New Product Development programs. Collaborate with the R&D and Sustaining organizations to help facilitate the successful execution of the NPD process and launching of robust products Develop experiments and tests (including writing and executing protocols) to create, validate, and improve products and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports. Investigate complaints from clinical cases, which may include: - Reviewing customer experience reports to determine potential device contribution - Hands-on evaluation of product returned from the field - Assess against risk management documentation, updating as necessary Support product release processes, including disposition of product and material quality control. Develop, update, and maintain technical content of risk management files (e.g. FMEAs, Quality Control Plans).. Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Implement and approve compliant change control. Support to external and internal audits. 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

Requirements

• Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience OR
• Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education

Nice To Haves

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Responsibilities

• Support design assurance and development activities (i.e., requirement development, risk assessment, engineering study, feasibility testing, drawing review, etc.) for New Product Development program
• Participate in test method development/validation activities for New Product Development programs.
• Collaborate with the R&D and Sustaining organizations to help facilitate the successful execution of the NPD process and launching of robust products
• Develop experiments and tests (including writing and executing protocols) to create, validate, and improve products and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Investigate complaints from clinical cases, which may include: - Reviewing customer experience reports to determine potential device contribution - Hands-on evaluation of product returned from the field - Assess against risk management documentation, updating as necessary
• Support product release processes, including disposition of product and material quality control.
• Develop, update, and maintain technical content of risk management files (e.g. FMEAs, Quality Control Plans)..
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Implement and approve compliant change control.
• Support to external and internal audits.
• 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

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees