Senior Engineer, Supplier Quality - Edwards Lifesciences
Irvine, CA
About the Job
Edwards Lifesciences has an opportunity for a Senior Engineer, Supplier Quality on the Transcatheter Mitral and Tricuspid Therapies (TMTT) team. This cross-functional position will have a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Engineer will apply knowledge of quality engineering principals and methods to ensure compliance with regulatory requirements and Edwards’ systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
Key Responsibilities:
+ Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
+ 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.
+ Continually assess the Supplier Management and QA Management system and SOP's for continual improvement
+ Drive deliverables to obtain Supplier approval.
+ Train, coach, and guide employees on routine procedures
Required Qualifications:
+ Bachelor’s degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required
+ Domestic and International Travel upwards of 25%
Preferred Qualifications:
+ Experience with class II and class III medical devices
+ Working knowledge of International and Domestic FDA regulations
+ Understanding of Manufacturing processes (i.e. Injection Molding, Extrusion, and Machining)
Additional Skills:
+ Effective communication and conflict resolution skills
+ Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
+ Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
+ Understanding of Risk Management principles
+ Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
+ Ability to manage competing priorities in a fast-paced environment
+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 $101,000 to $142,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
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.
Key Responsibilities:
+ Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
+ 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.
+ Continually assess the Supplier Management and QA Management system and SOP's for continual improvement
+ Drive deliverables to obtain Supplier approval.
+ Train, coach, and guide employees on routine procedures
Required Qualifications:
+ Bachelor’s degree (Engineering or Science) is required with 4 years of experience required or Master’s Degree (Engineering or Science) and 3 years of related experience required
+ Domestic and International Travel upwards of 25%
Preferred Qualifications:
+ Experience with class II and class III medical devices
+ Working knowledge of International and Domestic FDA regulations
+ Understanding of Manufacturing processes (i.e. Injection Molding, Extrusion, and Machining)
Additional Skills:
+ Effective communication and conflict resolution skills
+ Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
+ Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
+ Understanding of Risk Management principles
+ Six Sigma Green or Black Belt/LEAN Manufacturing experience a plus
+ Ability to manage competing priorities in a fast-paced environment
+ Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 $101,000 to $142,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
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