Quality Engineer II, NPD

Edwards Lifesciences • Irvine, CA

2d • $85,000 - $120,000

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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to oversee quality for new product development. How you will make an impact: • Develop, update, and maintain design control documentation through product development processes. Support development of design requirement documentation. • Develop, update, and maintain technical content of risk management and usability files • Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch. Participate in design verification and validation testing. • Investigate complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports. • Identify and ensure the optimization of complex Manufacturing and/or R&D 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/or test methods, and reduce risk. • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower-level employees on routine procedures • Other incidental duties assigned by Leadership

Requirements

• Bachelor's Degree in Engineering or Scientific field with 4 years’ experience related industry experience or
• Master's Degree or equivalent in Engineering or Scientific field with 3 years’ experience related industry or industry/education experience or
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Nice To Haves

• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Strong problem-solving, organizational, analytical and critical thinking skills
• Substantial understanding of processes and equipment used in assigned work
• Good leadership skills and ability to influence change
• Knowledge of applicable FDA regulations for medical device industry
• 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 inter-departmental teams and key contact representing the organization on contracts or projects
• 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

• Develop, update, and maintain design control documentation through product development processes.
• Support development of design requirement documentation.
• Develop, update, and maintain technical content of risk management and usability files
• Collaborate with R&D, manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch.
• Participate in design verification and validation testing.
• Investigate complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports.
• Identify and ensure the optimization of complex Manufacturing and/or R&D 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/or test methods, and reduce risk.
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• Train, coach, and guide lower-level employees on routine procedures
• 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