Manufacturing Engineer I

Edwards Lifesciences • Irvine, CA • 2h ago

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 delivering lasting solutions for unmet patient needs. Our Manufacturing Engineer I position offers a unique career opportunity to contribute to highly visible products and advance manufacturing excellence.

Imagine how your ideas and expertise can change a patient's life. Our Manufacturing Engineering - Pilot team plays a critical role in enabling robust, scalable manufacturing processes prior to full commercialization. In this role, you will partner cross-functionally with Manufacturing, Quality, R&D, and Operations teams to support pilot production, qualify processes and equipment, and drive continuous improvement within a regulated medical device environment.

How You'll Make an Impact:

Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement

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

Analyze and resolve basic 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

Establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis)

Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes

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 Scientific field

What Else We Look For (Preferred):

Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills

Basic understanding of statistical techniques

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

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

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

Good understanding of processes and equipment used in assigned work

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

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 immediate supervisor and other team members in the section or group; and may interact with vendors

Ability to build stable working relationships internally

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 (CA), the base pay range for this position is $69,000 to $98,000 (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.

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