Senior Technologist, R&DQA Engineering

Irvine, CA - USA

Monthly Salary: Not Disclosed

Posted on: 17 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 Technologist R&D/QA Engineering position is a unique career opportunity that could be your next step towards an exciting future.

How Youll 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
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
Train coach and guide lower level employees on new procedures assess work techniques and provide feedback to engineers on procedures
Design and build simple fixtures; 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 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
Other incidental duties (e.g. occasional photo copying or deliveries)

What Youll Need (Required):

Associates Degree or equivalent in or technical degree/certificate 8 Years experience in R&D Lab and/or medical device experience OR 10 Years related experience

What Else We Look For (Preferred):

Excellent written and verbal communication interpersonal and relationship building skills with focus on influencing and conveying recommendations
Problem solving methodology root cause analysis and GDP (Good Documentation Practices)
Strong computer skills including usage of MS Office Suite; and CAD if applicable
Extensive knowledge 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 and may propose solutions
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
Knowledge and understanding of statistical techniques and procedures
Ability to utilize CAD/drafting software (if applicable)
Knowledge and understanding of ECR 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 independently in completing assigned projects developing work instructions and advancing the competency of other technicians
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 the base pay range for this position is $70000 - $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

How Youll 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
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
Train coach and guide lower level employees on new procedures assess work techniques and provide feedback to engineers on procedures
Design and build simple fixtures; 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 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
Other incidental duties (e.g. occasional photo copying or deliveries)

What Youll Need (Required):

Associates Degree or equivalent in or technical degree/certificate 8 Years experience in R&D Lab and/or medical device experience OR 10 Years related experience

What Else We Look For (Preferred):

Excellent written and verbal communication interpersonal and relationship building skills with focus on influencing and conveying recommendations
Problem solving methodology root cause analysis and GDP (Good Documentation Practices)
Strong computer skills including usage of MS Office Suite; and CAD if applicable
Extensive knowledge 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 and may propose solutions
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
Knowledge and understanding of statistical techniques and procedures
Ability to utilize CAD/drafting software (if applicable)
Knowledge and understanding of ECR 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 independently in completing assigned projects developing work instructions and advancing the competency of other technicians
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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Required Experience:

Senior IC

Key Skills

Laboratory Experience
Vendor Management
Design Controls
C/C++
FDA Regulations
Intellectual Property Law
ISO 13485
Research Experience
SolidWorks
Research & Development
Internet Of Things
Product Development

Apply Now

About Company

Edwards Lifesciences

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

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