Job Information
Edwards Lifesciences Senior Quality Engineer, Test Method Development/Validation in Irvine, California
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.
In this Senior Quality Engineering role you will lead and contribute to Test Method (TM) development & validation supporting new product designs and launches in all phases on product development lifecycle. This includes equipment and automation validations for lab and manufacturing lines and product design verification and validation testing; including identifying critical inputs and outputs, analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion. You will serve functionally as a test method validation SME and develop technical troubleshooting capabilities.
How you will make an impact:
Lead and contribute to Test Method (TM) development & validation supporting new product designs and launches in all phases on product development lifecycle. This includes equipment validations for lab and manufacturing lines and product design verification and validation testing; including identifying critical inputs and outputs, analyzing results and developing reports; collaborate with cross-functional team members to facilitate project success and on-time completion.
Develop understanding of design intent and user needs to translate into product specifications and novel test methods.
Lead implementation activities (change control process) and ensure a robust feedback loop to development engineers.
Collaborate with different functions: R&D, Regulatory Affairs, Clinical Development, Manufacturing, Software Validation, Supplier Quality and external vendors.
Identify opportunities and implement re-design/design of basic equipment, tools, fixtures, etc. to improve or mistake-proof product testing and inspection processes. Deep-dive into complex technical opportunities when required.
Actively seek voice-of-customer feedback to ensure robust technical solutions meet expectations from key stakeholders.
Manage competing priorities in a fast-paced environment, including ongoing professional development.
Ability and willingness to travel up to 10%.
Other incidental duties assigned by Leadership.
What you’ll need (Required Qualifications):
Bachelor’s degree in engineering or Scientific related field with a minimum of four (4) years of experience within Manufacturing, mechanical design, R&D, Quality Engineering, or Quality Operations; OR Master's degree in Engineering or Scientific related field with a minimum of three (3) years experience.
Experience with adherence to GMP, GDP, Quality systems, and change controls in compliance with 21.CFR.820, ISO 13485, and other analogous regulations and laws.
Experience with authoring validation protocols and reports, equipment or product testing protocols, and procedures.
What else we look for (Preferred Qualifications):
Demonstrated experience with technical troubleshooting, failure analysis, root cause analysis/investigations, clear and concise technical writing, and corrective action implementation.
Working knowledge and application of statistical techniques including Gage R&R, Capability, Variance Analysis, and Design of Experiment (DOE).
Experience with advanced measurement equipment, techniques, and programming.
Proficiency with Solid Works, CREO, or similar tools for modeling, simulation, and design, with GD&T experience preferred
Automated measurement system programming experience (Keyence, Smartscope, etc)
Experience in highly regulated change control processes and risk management for product design and manufacturing processes.
Technical knowledge and experience with validation/qualification of processes, equipment, and/or software.
Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
Ability to interact professionally with all organizational levels.
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 $103,000 to $146,000 (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.