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 Quality position is a unique career opportunity that could be your next step towards an exciting future.

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.

How You'll Make an Impact:

Identify 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 of and ensure equipment, tools, fixtures, etc are up to standards

Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports

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

Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)

Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

Other incidental duties assigned by Leadership

What You'll Need (Required):

Bachelor’s degree in Engineering or a Scientific field with 4 years of relevant experience, or a Master’s degree with 3 years of relevant experience in industry or a combination of industry and education.

What Else We Look For (Preferred):

Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

Basic understanding of statistical techniques

Previous experience working with lab/industrial equipment required (if applicable)

Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

Strong problem-solving, organizational, analytical and critical thinking skills

Substantial understanding of processes and equipment used in assigned work

Good leadership skills and ability to influence change

Knowledge of applicable FDA regulations for medical device industry

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

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

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.