Senior Process Engineer, Advanced Catheter

Edwards Lifesciences

Irvine, CA

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JOB DETAILS

SALARY

$108,000–$153,000 Per Year

SKILLS

Analysis Skills, Cardiac Surgery, Cardiovascular Disease, Catheterization, Change Control, Clinical Support, Communication Skills, Compensation and Benefits, Computer Skills, Consulting, Cross-Functional, Detail Oriented, Documentation, Environmental Health, Healthcare Providers, International Operations, Interpersonal Skills, Inventory Planning, Lean Six Sigma, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Manufacturing Process Engineering, Manufacturing/Industrial Processes, Medical Equipment, Microsoft Office, Patient Care, Pollution Prevention, Polymers, Process Engineering, Process Improvement, Project Management Software, Project Planning, Regulations, Relationship Management, Reporting Skills, Risk Analysis, Safety/Work Safety, Sales, Sales Management, Six Sigma Black Belt, SolidWorks, Strategic Planning, Supply Chain, Team Player, Test Plan/Schedule, Vaccination, Vendor/Supplier Management, Warehousing

LOCATION

Irvine, CA

POSTED

30+ days ago

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality 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.

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.

How you'll make an impact:

+ Develop complex manufacturing processes using engineering methods (e.g., LEAN methods, Six Sigma)

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

+ Ensure that the processes under your property comply with current practices through the process of change control

+ Applies technical knowledge of complex equipment that improves manufacturing processes

+ Develop and implement training and documentation materials (for example, work instructions) for production in order to allow the uninterrupted transfer of knowledge of the manufacturing processes and projects

+ 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.)

+ Supervise manufacturing support tasks, ensure compliance; give instructions to the technicians about conducting tests; train technicians and provide feedback; and coordinate the technical work

+ Other additional tasks may be assigned by the area leader

What you'll need (Required):

+ Bachelor's Degree in an Engineering or Scientific field with 4 years of experience including either industry OR

+ Master's Degree or equivalent in an Engineering or Scientific field with 3 years of experience OR

+ Ph.D. or equivalent in an Engineering or Scientific field

What else we look for (Preferred):

+ Lean Six Sigma Black Belt

+ Manufacturing experience

+ Experience working within the medical device industry

+ Polymer experience

+ Experience working with catheters

+ Experience with reflow technology

+ SolidWorks certification

+ Good computer skills in the use of MS Office Suite

+ Strong documentation, communication (for example, written and verbal) and interpersonal relationship skills, including consulting skills and relationship management

+ Proven knowledge of statistical techniques

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

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

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

+ Strict attention to detail

+ Ability to manage competitive priorities in a fast-paced environment

+ Ability to work in a team environment, including the ability to manage suppliers and project stakeholders

+ Ability to comply with the standards, regulations, procedures and quality manuals applicable to Edwards Lifesciences

+ 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 $108,000 to $153,000 (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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