Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer, Manufacturing position is a unique career opportunity that could be your next step towards an exciting future.

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.

As a Senior Manufacturing Engineer, you will join our Transfer Engineer team, responsible for introducing new and innovative products and processes to the commercial manufacturing environment, which strike the necessary balance between unmet patient needs and required operational excellence.

How you will make an impact:

Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) offering significant voice-of-factory feedback to enable the re-design/design of and ensuring equipment, tools, fixtures, etc. exceed commercial manufacturing objectives.Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports.Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, validation findings, audit observations).Developing training and documentation materials (e.g., work instructions and engineering best practices) for commercial production partners to enable the seamless knowledge transfer of project and manufacturing processes.Leading and establishing project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).Overseeing manufacturing support tasks; giving instruction to technicians on conducting tests; training technicians and providing feedback; and coordinating technician work.

What you’ll need (Required):

A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required.

What else we look for (Preferred):

Proven expertise in usage of MS Office Suite including MS ProjectStrong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesSubstantial understanding and knowledge of principles, theories, and concepts relevant to EngineeringStrong problem-solving, organizational, analytical and critical thinking skillsSubstantial understanding of processes and equipment used in assigned workGood leadership skills and ability to influence changeKnowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturingKnowledge of applicable FDA regulations for medical device industryStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

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.