Clinical Engineer II

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: May 21, 2023

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience.Join us to incubate and explore world-class innovations in Structural Heart Disease to substantially improve patient outcomes.
-The Clinical Engineer II - Advanced Technology, is an outstanding opportunity to join an early-stage product development group. Edwards Advanced Technology is passionate about developing solutions for patients suffering from structural heart disease. We are seeking talented and agile clinical/engineering professionals to join this fast-paced, dynamic team and play a central role in the development of new therapies and devices, from concept though early human-use and pivotal trials. As the Clinical Engineer II you will be participate in procedure development, model development, clinical education, investigations, and case support for early human use trials.

This role is based in Irvine, California.Key ResponsibilitiesDevelop and implement pre-clinical test strategy and provide guidance to team members on strategy execution.Design, prepare and conduct first-in-man product evaluations, including case support for proper product use.Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals.Provide product expertise for new product introduction training for clinical and site personnel.Develop, review, and update clinical design control documents including technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in moderately complex product development.Ensure medical and scientific factors are considered during cross-functional product development project team meetings.Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports.Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.Provide guidance on clinical development requirements to the cross-functional team on the successful completion of product lifecycle management for all projects including those with significant complexityCreate procedural training for external physicians and other clinical personnelParticipate in device preparation for device procedures for early feasibility studiesParticipate in case reviews and investigations as needed to continually improve the procedure and provide feedback for next generation devicesPerform CT segmentation to create patient specific modelsCreate physiologic models for physicians trainingMinimum QualificationsBachelor's Degree or equivalent in engineering with 2 years previous related experience in Class II and III medical device technologies and/or clinical studies backgroundExcellent written and verbal communication skills and interpersonal relationship skillsDemonstrated problem-solving and critical thinking skillsAbility to manage competing priorities in a fast-paced environmentAbility to travel up to 30% within U.S. Additional Skills Moderate understanding of pre-clinical testing protocols, hospital environments and sterile techniques. Cath Lab experience desired.Moderate knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery; Experience with documentation management systems preferredExperienced in analyzing and presenting data. -Ability to manage confidential information with discretionHigh level of attention to detailAbility to interact professionally with all organizational levelsAligning 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 $81,000 to $114,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. 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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. 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.About Us 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 world's 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 15,000 individuals worldwide. - For us, helping patients is not a slogan - it's our life's 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Clinical Engineer II, Engineering , Irvine, California