Job description

This is a exciting opportunity to join an innovative team within the Edwards Transcatheter Mitral & Tricuspid Therapies (TMTT) business unit. TMTT is dedicated to lead and transform treatment for patients with mitral and tricuspid valve disease.
This Senior Quality Engineer will support the NPI Quality team applying technical knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements in optimizing product adoption, internal and external device manufacturing, and device distribution.

This position is based onsite at the Irvine Corporate Campus location.

Key Role Responsibilities:
Develop and execute complex experiments and tests (including writing and executing protocols) to validate and improve commercially launched products (including expansion of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.

Update and maintain technical content of risk management files.

Investigate complex product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.

Identify and ensure optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous improvement. Identify opportunities for continuous improvement for redesign/design of processes, basic equipment, tools, fixtures, etc. to improve processes and reduce risk.

Analyze and resolve complex manufacturing, field, and compliance issues (e.g., CAPA, PRA, non-conformances, audit observations) for all processes following commercial product release based on engineering principles; analyze results, make recommendations and develop reports.

Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

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

Train, coach, and guide lower-level employees on routine procedures

Other incidental duties assigned by Leadership

Required Education and Experience:
Bachelor's Degree in Engineering or Scientific field plus minimum of four (4) years relative quality engineering experience required

Masters Degree in Engineering (or Scientific field) will offset one (1) year required experience

Engineering Experience within Medical Device or relative FDA regulated industry highly preferred

Other Skills and Expectations

Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering and NPI process

Ability to lead and influence in a cross functional teams environment.

Demonstrated knowledge of applicable FDA regulations for medical device industry

Professionally efficient usage of MS Office Suite including Outlook, Word, Excel and MS Project; CAD experience preferred

Working knowledge and understanding of statistical techniques

Professional documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.

Previous experience working with lab/industrial equipment required

Demonstrates efficient problem-solving, analytical and critical thinking skills

Ability to interact professionally with all organizational levels

Ability to manage competing priorities and deliverable deadlines in a dynamic environment

Adhere to all EHS rules and requirements 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
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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 $101,000 to $142,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
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