- Senior
- Escritório em Irvine
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you will make an impact:
SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in support of the widest range of engineering activities such as test, check-out, modification, fabrication and assembly; including identifying potential improvement opportunities and proposing technical solutions to optimize products, processes, and/or equipment
Build complex prototypes, sub-assemblies, and prepare feasibility test units, samples, and/or chemical solutions; may include making material recommendations
Design and build simple fixtures; using sketches, CAD, etc
Perform test method development and validation for equipment and product designs
Train, coach, and guide lower level employees on new procedures, assess work techniques, and provide feedback to engineers on procedures
Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions
May build prototypes for physician demonstration
Perform complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans to perform testing, checkout, and trouble-shooting functions
Collect, document, and analyze test data
Operate a wide range of lab equipment including set-up, clean-up, break-down, and re-assembly
May create and modify drawings and procedures for fixtures, equipment, products, or processes
May initiate ECRs (Engineering Change Request)
On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period
What you'll need (Required):
Associate's Degree +8 years of experience in R&D Lab and/or medical device -or- 10 years of experience in R&D Lab and / or medical device experience
What else we look for (Preferred):
Ability to run hydrodynamic testing with anatomical models strongly preferred
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 if applicable
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 measuring equipment
Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
Strong team player with focus on collaborations and supporting other team members
Ability to utilize CAD/drafting software (if applicable)
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 independently including formulating work instructions and providing guidance and training to lower-level employees
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 (CA), the base pay range for this position is $68,000 to $97,000 (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.
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