Edwards Lifesciences Senior Quality Engineer, Commercial Quality (THV) in Irvine, California
The Senior Quality Engineer, Commercial Quality will play a key role in support of Edwards transcatheter aortic valve therapies. This role is responsible for leading and supporting key projects associated with our commercialized THV products. This includes support of product configuration changes, providing design control expertise for supply-chain driven manufacturing improvements, leading investigations into field performance issues and support of product labeling and training updates associated with our global therapy expansion.
This role will partner closely with other downstream functions in THV including post-market surveillance, global complaint handling and engineering, marketing, regulatory, and the sustaining R&D and supply chain teams. Additionally, this role will partner with upstream product development functions to transfer product design knowledge to post-market teams and to provide a feedback loop for THV field performance data.
Essential job functions include :
Provide Quality Engineering input to THV commercialized product projects including application of design control and risk management
Be a subject matter expert on field performance of THV devices and the design features associated with key performance metrics
Adaptable to broad scope of projects including material changes, manufacturing improvements, packaging and labeling changes, use instruction and usability changes.
Excellent technical writing and presentation skills to support internal and external communication into field performance investigations
Build partnerships with key cross functional stakeholders
Stay current with Edwards THV operations and market trends
Lead or support investigations including CAPAs resulting from design or product use root causes of commercialized products
Support Edwards THV global expansion through Quality Engineering support for geographic specific changes
Support sustaining engineering projects led by sustaining R&D and Global Supply Chain for commercialized THV products
Use Green Belt and Black Belt methodologies to support investigations into field performance issues
Support for internal and external audits of the THV business
Maintain expertise in applicable global regulations affecting THV Commercial Quality including 21 CFR 820, ISO 13485 and EU MDR
Ability to travel up to 10%
Bachelor's Degree required in an engineering or scientific field, plus (4) years of experience in quality engineering; OR Master’s Degree in engineering or scientific field, with (3) years of experience in quality engineering
Lifesciences industry experience (i.e. medical device, pharma, or biotech)
Experience with design controls, design verification & validation, or design test method development
Demonstrated experience reviewing and updating risk management related documents
Experience utilizing statistical techniques to support design decisions and product acceptance testing
Master's Degree in an engineering, scientific or a related discipline
Medical device industry experience highly preferred.
Experience in catheter-based therapies preferred.
Design control and design change experience for product improvements
Experience with sustaining activities for commercialized products
Experience in post market investigations, CAPA investigation, development or manufacturing of transcatheter based therapies
Strong experience in quality engineering, R&D or manufacturing engineering
Design for Six Sigma or Lean Six Sigma Certification (Green belt or black belt)
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.