Senior Principal Engineer, R&D - 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.
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our R&D Engineering team, the Senior Principal Engineer will be part of a highly talented team of engineers working on new product development for Edwards Life sciences Transcatheter Heart Valve to address significant, unmet clinical needs that impact patients’ lives around the world.
How you'll make an impact:
+ Drive the development and manage the execution of highly complex experiments and tests (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
+ Initiate and lead the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design on new products and/or processes, etc. are up to standards
+ Train, coach, and guide lower level employees on highly complex procedures
+ Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
+ Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
+ Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
+ May be selected as an Independent Reviewer for design review
+ Other incidental duties
What you’ll need (Required):
+ Bachelor's Degree in Engineering or Scientific field and 8+ years of experience, including either industry or industry/education - OR
+ Master's Degree in Engineering or Scientific field and 7+ years of experience, including either industry or industry/education - OR
+ Ph.D. in Engineering or Scientific field and 4+ years of experience, including either industry or industry/education
What else we look for (Preferred):
+ Experience with failure analysis tools and methods
+ Proven expertise in usage of MS Office Suite; CAD experience preferred
+ Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
+ Ability to translate complex and technical information to all levels of the organizations
+ Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines
+ Expert understanding of processes and equipment used in assigned work
+ Strong leadership skills and ability to influence change
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Represents organization as key technical contact on contracts and projects
+ Interacts with senior external representatives on significant technical 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 $133,000 to $187,000 (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.
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. As part of our R&D Engineering team, the Senior Principal Engineer will be part of a highly talented team of engineers working on new product development for Edwards Life sciences Transcatheter Heart Valve to address significant, unmet clinical needs that impact patients’ lives around the world.
How you'll make an impact:
+ Drive the development and manage the execution of highly complex experiments and tests (including writing and executing protocols) on a platform which includes multiple product lines to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion
+ Initiate and lead the identification and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design on new products and/or processes, etc. are up to standards
+ Train, coach, and guide lower level employees on highly complex procedures
+ Lead and establish highly complex project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
+ Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
+ Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
+ May be selected as an Independent Reviewer for design review
+ Other incidental duties
What you’ll need (Required):
+ Bachelor's Degree in Engineering or Scientific field and 8+ years of experience, including either industry or industry/education - OR
+ Master's Degree in Engineering or Scientific field and 7+ years of experience, including either industry or industry/education - OR
+ Ph.D. in Engineering or Scientific field and 4+ years of experience, including either industry or industry/education
What else we look for (Preferred):
+ Experience with failure analysis tools and methods
+ Proven expertise in usage of MS Office Suite; CAD experience preferred
+ Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
+ Ability to translate complex and technical information to all levels of the organizations
+ Recognized as an expert in own area within the organization while applying broad-based technical expertise and has full knowledge of other related disciplines
+ Expert understanding of processes and equipment used in assigned work
+ Strong leadership skills and ability to influence change
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to manage competing priorities in a fast paced environment
+ Represents organization as key technical contact on contracts and projects
+ Interacts with senior external representatives on significant technical 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 $133,000 to $187,000 (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