Engineer II, Quality

Innovation starts from the heart. Edwards Lifesciences i is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering

lasting solutions for unmet patient needs. Our Engineer II, Quality position is a unique career opportunity that could be your next step towards an exciting future.

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

Applies 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 before final product release based on engineering principles; analyze results, make recommendations, and develop reports.

• Plan, direct, and approve supplier validations, capability analyses, and gage studies based on risks identified in FMEAs 

• Collaborate with Corporate Supplier Quality and drive activities related to Notice of Changes affecting Implant Network with a focus on Irvine Plant  

• Develop, update, and maintain technical content of risk management files

• Continually assess the Receiving Inspection and QA Management system and SOPs for continual improvement 

• Update Supplier files impacting the Irvine plant.

• Assign support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Other incidental duties assigned by Leadership

What You'll Need (Required):

• Bachelor's Degree in Engineering or Scientific field, 2 years experience related work experience Required or

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

What Else We Look For (Preferred):

• 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 the environment and prevention of pollution under their span of influence/control

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.

For California, the base pay range for this position is $83,000 to $117,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.   

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.