Manufacturing Engineer II

Edwards Lifesciences

Irvine, CA

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JOB DETAILS

SALARY

$87,000–$123,000 Per Year

SKILLS

Analysis Skills, Cardiovascular Disease, Cleanroom, Communication Skills, Compensation and Benefits, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Detail Oriented, Documentation, Environmental Health, FDA Requirements, Healthcare Providers, Inventory Planning, Knowledge Transfer, Laboratory, Laboratory Equipment, Leadership, Lean Six Sigma, Manufacturing, Manufacturing Engineering, Manufacturing Operations, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Office, Microsoft Project, Patient Care, Presentation/Verbal Skills, Process Improvement, Project Management Software, Project Planning, Public/Media/Press/Analyst Relations, Reporting Skills, Risk Analysis, Safety/Work Safety, Sales, Strategic Planning, Supply Chain, Team Player, Technical/Engineering Design, Test Plan/Schedule, Training/Teaching, Vaccination, Vendor/Supplier Management, Warehousing, Writing Skills

LOCATION

Irvine, CA

POSTED

30+ days 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 discovering lasting solutions for unmet patient needs. Our Manufacturing Engineer II 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 Global Supply Chain team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

How you’ll make an impact:

+ Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes

+ Optimize manufacturing processes using engineering methods (e.g., Six Sigma and Lean) for continuous improvement and/or the design/re‑design of equipment, tools, fixtures, etc., employing strong technical design skills

+ Develop moderately 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 moderately complex manufacturing and compliance issues (e.g., CAPA, non‑conformances, audit observations)

+ Develop training and documentation materials (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes

+ Establish project plans to ensure deliverables are completed to customer expectations, using project management tools (e.g., project plans, risk analyses)

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

+ Perform other incidental duties as assigned by leadership

What you’ll need (Required):

+ Bachelor's Degree in Engineering or Scientific field plus 2 years related experience

+ Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or related Scientific field including either industry or industry/education

What else we look for (Preferred):

+ Proficiency with MS Office Suite, including MS Project; CAD experience preferred (as applicable)

+ Strong documentation and communication skills (written and verbal), with effective consultative and relationship‑management abilities

+ Basic understanding of statistical techniques

+ Prior experience working with laboratory or industrial equipment (as applicable)

+ Solid understanding of engineering principles, theories, and concepts

+ Strong problem‑solving, organizational, analytical, and critical‑thinking skills

+ Strong understanding of the processes and equipment used in assigned work

+ Knowledge of, and adherence to, Edwards Environmental Health & Safety and Quality guidelines related to clean‑room medical device manufacturing

+ Knowledge of applicable FDA regulations for the medical device industry

+ Exceptional attention to detail

+ Ability to interact professionally across all organizational levels

+ Ability to manage competing priorities in a fast‑paced environment

+ Ability to work effectively in a team environment, including managing vendors and project stakeholders

+ Ability to build productive internal and external working relationships

+ Commitment to adhering to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules), and taking appropriate measures to prevent injuries, protect the environment, and prevent pollution within their scope of influence and 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 $87,000 to $123,000 (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.

About the Company

Edwards Lifesciences

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