Senior Quality Engineer, New Product Transfers - Edwards Lifesciences
Irvine, CA
About the Job
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How You Will Make an Impact:
+ Oversees and able to prioritize multiple Product Transfers from Pilot and Product development teams
+ Build trusted partnerships with key cross functional stakeholders and other Implant sites
+ Communicates and drives sustaining initiatives to pilot and product development teams
+ Early integration in Design Phase
+ Quality Voice of Factory Lead for all product transfers
+ Supporting product development teams in verifying clear requirements and specifications are defined and assessing the corresponding Risk Files as part of product transfer
+ Support Digital Transformation with SPC, SCADA and MES Integration
+ Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
+ Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
+ Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
+ Be a key liaison to Irvine Implant site for knowledge of new products
+ Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower level employees on routine procedure
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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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 15,000 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.
Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How You Will Make an Impact:
+ Oversees and able to prioritize multiple Product Transfers from Pilot and Product development teams
+ Build trusted partnerships with key cross functional stakeholders and other Implant sites
+ Communicates and drives sustaining initiatives to pilot and product development teams
+ Early integration in Design Phase
+ Quality Voice of Factory Lead for all product transfers
+ Supporting product development teams in verifying clear requirements and specifications are defined and assessing the corresponding Risk Files as part of product transfer
+ Support Digital Transformation with SPC, SCADA and MES Integration
+ Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
+ Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
+ Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
+ Be a key liaison to Irvine Implant site for knowledge of new products
+ Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Train, coach, and guide lower level employees on routine procedure
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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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 15,000 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.
Source : Edwards Lifesciences