Senior Engineering Technologist, Test Method Development
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company driven by a passion to improve patient lives. With millions of patients served in over 100 countries each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineering Technologist position is a unique career opportunity that could be your next step towards an exciting future.
The Senior Engineering Technologist will support all TMTT new product development projects focusing on test method development and validation for supplied components. This individual will work cross-functionally with R&D Quality Engineering Supplier Quality Engineering Supplier Engineering and Manufacturing to understand design requirements and intended use of components in the finished delivery system. This individual will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
How you will make an impact:
- Support a wide range of engineering activities such as development of more complex tool methods and related validations for various measurement applications under minimal supervision of Engineers; and may propose technical solutions
- Build complex prototypes sub-assemblies and prepare feasibility test units; may include making material recommendations
- Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions
- Design and build simple to complex fixtures or gages; using sketches CAD etc
- Perform test method development and validation for equipment and product designs
- May create and modify drawings and procedures for fixtures equipment products components or processes
- Develop documentation and procedures in support of the inspection of components
- Perform more complex work using statistical analysis such as capability gage R&R method comparison and statistical process control
- Support Receiving & Inspection and personnel in a cleanroom environment
- Collect analyze and document test data
- Order and maintain test lab/cleanroom supplies and equipment
- Initiate assist and manage change management process for documentation and supplier changes through PLM and SQMS systems
- Other duties assigned by Management including representing the department in corporate level initiatives.
What youll need (Required):
- Associates Degree (or technical degree/certificate) with (8) years of experience in R&D Lab and/or medical device industry; OR (10) years of experience with engineering support design quality manufacturing or supporting with new product development
- Hands-on experience with Test Method Development
- Ability and willingness to travel up to 10% primarily within the U.S. with occasional international travel as required.
What else we look for (Preferred):
- Experience working within a regulated industry
- Test Method Development experience with programming and executing measurement routines using visionbased inspection systems (e.g. Keyence SmartScope CMMs) to support dimensional inspection and routine measurements for development and production use.
- Handson experience developing executing and validating inspection and test methods to support pilot and commercial product launches (Test Method Development/Validations).
- Strong practical experience with Gage R&R and measurement system analysis including creating validation documentation and executing studies.
- Proven ability to design build and troubleshoot fixtures to support manual and automated inspection processes.
- Working knowledge of GD&T with the ability to interpret drawings and apply tolerances appropriately within test method development; SolidWorks experience preferred.
- Strong documentation skills including test protocols work instructions and and technical reports with proficiency in MS Office.
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 $70000 to $99000 (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.
Required Experience:
Senior IC
Key Skills
- SQL
- Active Directory
- Powerpiont
- API
- OSHA
- Test Equipments
- Linux
- Technology Services
- Internet
- QA
- PC
- Computer System
- Setup
- hardware
- Test Results
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
