Manufacturing Engineer II, Advanced Catheters Pilot Request Location: USA, Califor - Irvine, United States - Edwards

Description

Edwards Lifesciences Careers

Manufacturing Engineer II, Advanced Catheters Pilot

Contract type Full time


Location USA, California, Irvine


Job reference Req-9725


Posted for 84 Days

Edwards Lifesciences has a new opening for a Manufacturing Engineer II - Advanced Catheters Pilot, supporting our Global Supply Chain - Irvine Pilot Operations.

The mission of Irvine Pilot Operations is to enable Edwards to achieve rapid product development cycles coupled with exceptional product reliability, efficient cost, and real-time product transfers through a strong partnership with the NPD teams and the global plant network.

The Manufacturing Engineer II will support engineering and validation activities related to establishing equipment capabilities, equipment procurement, IQ/OQ, process development, initial stabilization of new and in-sourced steerable catheter shafts for early human use as well as support of transfer activities.

Additional objectives may include setting and optimizing cleanroom configuration and layouts to improve quality and performance.

This role will directly interact with the Advanced Catheter COE and other cross-functional engineering resources to support development and transfer of new processes and technologies to manufacturing.

Key Responsibilities:

• I dentify and support 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 and ensure equipment, tools, fixtures, etc are up to standards.
• Support analysis and resolution of Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
• Support experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
• Support training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
• Support project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
• Support manufacturing tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
• Perform other duties and responsibilities as assigned.

Basic Qualifications:

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

Preferred Qualifications:

• Class II and Class III medical device manufacturing experience is preferred.
• Lean / Six Sigma knowledge and practical use of tools is preferred.
• Knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
• Problem-solving, organizational, analytical and critical thinking skills.
• Effective communication and project management skills are required.
• Strong analytical, problem solving, and technical writing skills.
• Ability to work well independently based on minimal guidance.
• Strong interpersonal and intercultural skills are required.

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 patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility 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.

For United States Applicants Only:
EEO is the Law

for more information regarding Equal Employment Opportunity

Disability accommodation for employment applicants
Reasonable accommodation will be provided for qualified individuals with disabilities and disabled veterans in job application procedures.

If you have any difficulty using our online system and need an accommodation due to a disability, you may contact us at for assistance.

Please include a description of your requested accommodation, your name and contact information.

Note:
This email address is not for general employment inquiries.

Edwards will not respond to inquiries that are not related to accessibility of the on-line application system by individuals with disabilities.

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