Senior Technologist, R&D/QA Engineering

Edwards Lifesciences•Irvine, CA

3d•$70,000 - $99,000

About The Position

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 You'll 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)

Requirements

Associate's 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

Nice To Haves

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

Responsibilities

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)

Benefits

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.

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