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 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.
Top Skills
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more.
Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today.
Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives.
Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life.
For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms