Please note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.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.This Senior Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.How you will make an impact:
Apply knowledge of Design Control principles and quality engineering to positively influence new product development efforts, including those for design verification, validation, and specification development.
Support new product development programs in the areas of Risk Management, Design Control, Usability Engineering, Statistical Techniques, and Regulatory Compliance as needed.
Collaborate with R&D to develop design requirements and support design freeze, design verification and validation testing
Lead test method development and validation activities for new designs
Lead failure investigations for product failures in design testing and clinical use
Develop and implement inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
Performs other incidental duties as assigned by management
What you'll need (Required Qualifications):
Bachelor’s Degree in Engineering or Scientific field with a minimum of four (4) years of combined experience in Quality Engineering, R&D, and/or Manufacturing; OR a Master’s Degree in Engineering or Scientific field with a minimum of three (3) years of combined experience in Quality Engineering, R&D, and/or Manufacturing.
Engineering experience within a highly regulated industry
What else we look for ( Preferred Qualifications) :
Medical device industry experience
Quality Engineering experience in New Product Development from initial concept to commercialization.
Hands-on experience with Design Assurance, including Design Controls, Design Verification & Validation, and Design Test Method Development
Class III new product development experience
Knowledge of and experience with Risk Management/Usability Engineering and authoring risk management documents.
Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)
Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
Ability to prioritize, plan, and evaluate deliverables to established strategic goals
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 stakeholders representing the organization on projectsASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
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 $115,000 to $163,000 (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 RequirementEdwards 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.
