Technologist, R&D Job at Edwards Lifesciences, Irvine, CA

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  • Edwards Lifesciences
  • Irvine, CA

Job Description

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around 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. This is an exciting opportunity for a Technologist to join the THV team to support new equipment and innovative technologies. In this role, this Technologist will have the opportunity to travel to external vendors to induct new equipment to our Irvine facility. **How you will make an impact:** + Performing Equipment Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). + Operating a wide range of equipment including set-up, clean-up, break-down, and re-assembly. Performing test method development and validation for equipment. + Performing operational test and identifying failure modes on systems and equipment and proposing and implementing technical solutions. Collecting, documenting, and analyzing test data. + Checking for failures in equipment and performing corrective actions to affected areas that have down time, including conducting and writing impact assessment reports of incidents. + Performing both scheduled and unscheduled preventive maintenance routines on a wider range of complex equipment. + Applying in-depth knowledge of processes in the use of machines to ensure successful outcomes, as well as to devise complex process changes. + Designing and building simple fixtures; using sketches, CAD, etc. + Training, coaching, and guiding lower-level employees on new procedures, assess work techniques and providing feedback to engineers on procedures. + Creating and modifying drawings and procedures for fixtures, equipment, products, or processes. + Supporting a wide range of engineering activities such as test, check-out, modification, fabrication and assembly; formulating and proposing technical solutions. Building complex prototypes, sub-assemblies, and preparing feasibility test units, samples, and/or chemical solutions. Performing complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions. + On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period. + Flexible work schedule with the ability to travel domestically as needed. **What you'll need (Required):** + Associate's Degree with 4 years of previous related experience OR H.S. Diploma with 6 years of previous related experience Required. **What else we look for (Preferred):** + AC/DC electrical experience with the ability to read electrical schematics + Knowledge of various hand tools for testing circuitry + Proficient in Maximo (equipment management system) + Proficient in performing IQ & TFIQ + PLC knowledge + Strong written and verbal communication, interpersonal, and relationship building skills + Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices) + Strong computer skills, including usage of MS Office Suite, and CAD + Full understanding of equipment in a lab environment + Ability to perform complex troubleshooting + Ability to identify problems and relevant issues in complex situations, assessing using standard procedures + Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such as measuring equipment + Ability to read and understand procedures, drawings, schematics and carry out assembly instructions + Knowledge and understanding of statistical techniques and procedures + Ability to utilize CAD/drafting software, 3D printing, laser printing + Knowledge and understanding of change request software systems + Ability to draft technical documents (i.e., manufacturing and testing procedures) + Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing + Strict attention to detail + Must be able to work in an inter-departmental team environment, as well as with colleagues from other departments and represent organization to outside contacts, i.e., vendors + Ability to provide feedback in a professional, direct, and tactful manner 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 $60,000 to $84,000 (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.

Job Tags

Flexible hours,

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