Edwards Lifesciences Careers

**Engineer II, Quality - Advanced Catheter COE Pilot**

* **type** Full time

* **Location** USA, California, Irvine

* **Job reference** Req-13230

* **Posted for** 14 Days

Edwards Lifesciences has a new opening for a Quality Engineer II Advanced Catheters Pilot, supporting our Global Supply Chain Irvine Pilot Operations. The Advanced Catheter Center of Excellence (COE) Pilot Team aims to vertically integrate advanced catheter manufacturing processes within Edwards Lifesciences to continue elevating our capacity to serve patients with improved reliability and efficiency.

The Quality Engineer II will support the Advanced Catheter COE goal of establishing and operating a new clinical manufacturing operation for Polymer Extrusions and Advanced Catheter Manufacturing. The engineer will work closely with R&D & Pilot engineering counterparts within the COE to understand prototype design and product clinical use to setup and optimize scale-up ready and clinical capable manufacturing operations.

Key Responsibilities:

* Proficiency in Extrusions and Advanced Catheter Manufacturing and Inspection/Testing concepts and line operation.

* Identify, support and own implementation of opportunities to optimize manufacturing processes, product testing methods and characterization utilizing engineering methodologies (e.g. Six Sigma/DMAIC, LEAN).

* Identify, support and own studies to identify and control critical product failure modes

* Support and own experiments (including writing and executing protocols and technical summaries) to qualify and validate manufacturing processes and test methods (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.

* Compilation and understanding of process and inspection data to troubleshoot and propose solutions to manufacturing and/or quality issues; establish correlations, understand data trends, and provide engineering recommendations for improvement.

* Support deployment of automated inspection platforms and creation of automated inspection routines/workflows.

* Support implementation of risk control methodologies (e.g. Critical Control Points, FMEA/Mistake Proofing)

* Creation and maintenance of Standard Operating Procedures (SOPs) and Work Instructions for manufacturing and inspection of product.

* Support manufacturing tasks; give instruction to technicians and operators on completing operations and/or conducting tests; training of technicians and operations and coordination of workstreams.

* Support asset management of tools and equipment; creation of Preventive Maintenance (PM) & Calibration work instructions; compilation of wear studies to support asset life cycle management.

* Evaluation of new technologies to support manufacturing and testing.

Basic Qualifications:

* Bachelors degree in engineering or scientific with 2 years of engineering experience.

Additional Qualifications:

* Eagerness to positively disrupt historical practices and established systems for future improvement.

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

* Strong MS Office (Word, Power Point, Excel) skills.

* Ability to manage competing priorities in a fast paced environment.

* Knowledge and understanding of medical device product development processes.

* Knowledge and understanding of quality systems and risk management.

* Manufacturing/Production line experience.

**About Edwards Lifesciences**

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the worlds leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - its our lifes work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

**COVID Vaccination Requirement**

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.