r Quality Engineer - NPD/Design Assurance

Edwards Lifesciences•Irvine, CA

1d•$108,000 - $153,000

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. 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 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., device evaluations, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports. • 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 in Engineering or related field, 4 years related industry experience or
Master's Degree or equivalent in in Engineering or related field, 3 years’ experience related industry or industry/education experience or
Ph.D. or equivalent in in Engineering or related field, 0 years’ experience

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 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., device evaluations, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyze results, make recommendations and develop reports.
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