Senior Quality Engineer, Commercial Quality & Sustaining - Edwards Lifesciences
Irvine, CA
About the Job
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.
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 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.
How you will make an impact
+ 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
+ Lead or support Product Risk Assessments
+ 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%
What you'll need ( Required Qualifications):
+ 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
What else we look for ( Preferred Qualifications):
+ 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, complaint 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)
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.
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 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.
How you will make an impact
+ 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
+ Lead or support Product Risk Assessments
+ 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%
What you'll need ( Required Qualifications):
+ 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
What else we look for ( Preferred Qualifications):
+ 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, complaint 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)
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.
Source : Edwards Lifesciences
