Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.This role is onsite, based out of the Edwards Global Campus Headquarters in Irvine, CA.How You Will Make an Impact:
Manage an engineering team for TMTT Design Assurance. Develop team members to increase business acumen and functional skills
Work cross functionally with R&D to refine and finalize the design, develop design requirements, perform testing of the design, and qualify the design per the Product Development Process (PDP).
Lead risk management and usability engineering activities and supports program strategy and the operations team to help develop inspection methods and facilitate successful transfer/launching of robust products.
Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables.
Identify opportunities and lead the implementation of changes to drive improvements
Other incidental management duties
What you will need (required):
Bachelor's Degree in Engineering or related field required. Master's Degree may offset some experience requirements.
People management experience required - including providing coaching and feedback, responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations.
Design Quality or Engineering Management experience in a regulated medical device or life sciences industry required.
What else we look for (preferred):
Hands on experience with valve, delivery system, sheath and/or catheter design, manufacturing processes, and testing experience considered a big plus.
Advanced understanding and knowledge of product development processes
Experience in relative Design Assurance functions including product risk management and usability engineering
Applicable knowledge and adherence to applicable regulatory requirements (e.g., ISO 13485, QSR)
Proven record of success project management leadership
Efficient / advanced utilization of Microsoft Office Suite (including Outlook, Excel, Word, Power Point, MS Project)
Demonstrates deep problem-solving, analytical and critical thinking skills including high discretion in decision making
Exhibits high level communication and relationship management skills with ability to drive achievement of objectives
Financial acumen experience as it relates to area (manage business unit budgets, forecasts, and cost center savings)
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality to the business
Strict attention to detail
Thrives in a cross functional, matrixed environment- able to build relationships and correspond professionally with all levels of the organization, external vendors and customers. Proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and rapidly changing work environment
Conducts presentations of technical information concerning specific projects and schedules - able to prepare information and provide problem-solving solutions; influence cross functional partners.
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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).Every employee is essential to Edwards’ success, and we’re ready to help you advance along your career path!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 or have a valid religious or medical exemption from being vaccinated.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.
