Principal Quality Engineer, New Product Development - 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.
This Principal Quality Engineer, New Product Development 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 :
+ Providing technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
+ Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
+ Lead development and drive updates to risk management files for new products
+ Lead test method development and validation activities for new designs
+ Lead failure investigations for product failures in design testing and clinical use
+ Lead development and implementation of 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.
+ Managing/overseeing the work of an assigned team of direct reports within own function.
+ Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.
+ Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
+ Performs other incidental duties as assigned by management
+ Ability to travel up to 10% domestically and internationally
What you'll need (Required Qualifications):
+ Bachelor’s degree in Engineering or Scientific field with a minimum of six (6) years related experience; OR a Master’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) years related experience.
+ 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)
What else we look for (Preferred Qualifications):
+ Current or prior experience within Medical Device industry
+ Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
+ Knowledge of and experience with risk management/usability engineering within medical device industry or other regulated industries
+ Quality Engineering experience in New Product Development
+ New Product Development experience from initial concept to commercialization (Class III preferred).
+ Experience with Risk Management and Design Control
+ Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations
+ Proven expertise in usage of MS Office Suite including MS Project
+ Basic understanding of statistical techniques
+ Strong problem-solving, organizational, analytical and critical thinking skills
+ Experience in people leadership including direct line reporting responsibilities
+ ASQ 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 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.
This Principal Quality Engineer, New Product Development 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 :
+ Providing technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
+ Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
+ Lead development and drive updates to risk management files for new products
+ Lead test method development and validation activities for new designs
+ Lead failure investigations for product failures in design testing and clinical use
+ Lead development and implementation of 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.
+ Managing/overseeing the work of an assigned team of direct reports within own function.
+ Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.
+ Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
+ Performs other incidental duties as assigned by management
+ Ability to travel up to 10% domestically and internationally
What you'll need (Required Qualifications):
+ Bachelor’s degree in Engineering or Scientific field with a minimum of six (6) years related experience; OR a Master’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) years related experience.
+ 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)
What else we look for (Preferred Qualifications):
+ Current or prior experience within Medical Device industry
+ Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
+ Knowledge of and experience with risk management/usability engineering within medical device industry or other regulated industries
+ Quality Engineering experience in New Product Development
+ New Product Development experience from initial concept to commercialization (Class III preferred).
+ Experience with Risk Management and Design Control
+ Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations
+ Proven expertise in usage of MS Office Suite including MS Project
+ Basic understanding of statistical techniques
+ Strong problem-solving, organizational, analytical and critical thinking skills
+ Experience in people leadership including direct line reporting responsibilities
+ ASQ 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 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
