Director, Engineering - 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.
How you’ll make an impact:
+ Lead a high performing, multi-disciplinary engineering team to develop and implement advanced tissue manufacturing process technology for Edwards’ Implant Network.
+ Collaborate with the Tissue & Biotechnology Center of Excellence (T&BCOE), Edwards New Product Development (NPD) and New Product Introduction (NPI) teams, and our global manufacturing sites to lead the discovery, development, acquisition, create fast-to-market, scalable, and cost-effective and operational integration of advanced tissue manufacturing process technology for structural heart valve applications.
+ Develop & manage advanced tissue manufacturing technology roadmaps to enable growth and speed of innovation.
+ Apply principles of biomechanics, mechanical design, laser, optics and vision systems engineering, automation, artificial intelligence and chemical process engineering and incorporate Six Sigma and Lean Manufacturing values to achieve Implant Network objectives.
+ Translate and integrate device design intent, Voice of the Factory & lessons learned to tissue technology solutions.
+ Conduct business case analysis and employ project portfolio management & estimating practices to assess projects and achieve technology adoption.
+ Build and maintain cross-functional partnerships across World-Wide Engineering, Manufacturing Operations, Quality, PMO, Business Excellence, Finance, R&D, Regulatory, Validation, Technical Training and Human Resources.
+ Ensure harmonized equipment and processes are effectively developed and implemented at each manufacturing site.
+ Employ Six Sigma and Lean Manufacturing principles to enable transformational technology and continuous improvement throughout the lifecycle.
+ Employ safety, ergonomic and automation principles in the design and implementation of process solutions.
+ Develop a robust talent development & succession plan in alignment with Implant Network growth strategies.
What you’ll need (Required):
+ Bachelor’s in engineering or scientific with 12 years of experience in manufacturing process engineering in highly regulated industry.
+ Demonstrated success leading technical professionals and managing large and diverse groups of stakeholders.
+ Strong technical knowledge and leadership in manufacturing engineering of medical devices including process excellence methodologies such as automation, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, Six Sigma, cGMP, supplier development and process validation.
+ Travel up to 20% internationally.
What else we look for (Preferred):
+ Advanced degree.
+ Demonstrated experience in the application of Six Sigma and Lean Manufacturing principles.
+ Successful track record developing and managing technology lifecycles in a manufacturing environment.
+ Excellent problem-solving, organizational, analytical, and critical thinking skills with a high degree of discretion & judgment.
+ Excellent documentation, communication, and interpersonal relationship negotiation and relationship management skills.
+ Demonstrated skill in acquisition of equipment and strong financial management skills associated with large capital and operating expense budgets.
+ Ability to influence, motivate and inspire employees, stakeholders, and senior leadership.
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 $152,000 to $216,000 (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.
How you’ll make an impact:
+ Lead a high performing, multi-disciplinary engineering team to develop and implement advanced tissue manufacturing process technology for Edwards’ Implant Network.
+ Collaborate with the Tissue & Biotechnology Center of Excellence (T&BCOE), Edwards New Product Development (NPD) and New Product Introduction (NPI) teams, and our global manufacturing sites to lead the discovery, development, acquisition, create fast-to-market, scalable, and cost-effective and operational integration of advanced tissue manufacturing process technology for structural heart valve applications.
+ Develop & manage advanced tissue manufacturing technology roadmaps to enable growth and speed of innovation.
+ Apply principles of biomechanics, mechanical design, laser, optics and vision systems engineering, automation, artificial intelligence and chemical process engineering and incorporate Six Sigma and Lean Manufacturing values to achieve Implant Network objectives.
+ Translate and integrate device design intent, Voice of the Factory & lessons learned to tissue technology solutions.
+ Conduct business case analysis and employ project portfolio management & estimating practices to assess projects and achieve technology adoption.
+ Build and maintain cross-functional partnerships across World-Wide Engineering, Manufacturing Operations, Quality, PMO, Business Excellence, Finance, R&D, Regulatory, Validation, Technical Training and Human Resources.
+ Ensure harmonized equipment and processes are effectively developed and implemented at each manufacturing site.
+ Employ Six Sigma and Lean Manufacturing principles to enable transformational technology and continuous improvement throughout the lifecycle.
+ Employ safety, ergonomic and automation principles in the design and implementation of process solutions.
+ Develop a robust talent development & succession plan in alignment with Implant Network growth strategies.
What you’ll need (Required):
+ Bachelor’s in engineering or scientific with 12 years of experience in manufacturing process engineering in highly regulated industry.
+ Demonstrated success leading technical professionals and managing large and diverse groups of stakeholders.
+ Strong technical knowledge and leadership in manufacturing engineering of medical devices including process excellence methodologies such as automation, DFM, LEAN, EH&S guidelines, FDA guidelines ISO standards, Six Sigma, cGMP, supplier development and process validation.
+ Travel up to 20% internationally.
What else we look for (Preferred):
+ Advanced degree.
+ Demonstrated experience in the application of Six Sigma and Lean Manufacturing principles.
+ Successful track record developing and managing technology lifecycles in a manufacturing environment.
+ Excellent problem-solving, organizational, analytical, and critical thinking skills with a high degree of discretion & judgment.
+ Excellent documentation, communication, and interpersonal relationship negotiation and relationship management skills.
+ Demonstrated skill in acquisition of equipment and strong financial management skills associated with large capital and operating expense budgets.
+ Ability to influence, motivate and inspire employees, stakeholders, and senior leadership.
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 $152,000 to $216,000 (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