Technologist, R&D

Edwards Lifesciences • Irvine, CA

5d • $61,000 - $86,000

About The Position

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease and critical care. 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. This Technologist, R&D has the opportunity to join an early-stage Transcatheter Mitral Valve Replacement (TMVR) program and support critical activities in designing a novel implant. If you’re an exceptional engineering technician professional with significant experience and a heart for solving complex challenges, join our team and help us improve patients’ lives through the development of a TMVR therapy from the ground up. How you’ll make an impact: Support a wide range of engineering activities such as test, check out, modification, fabrication and assembly; may formulate and propose technical solutions Design and 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 all 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 Generate reports and support recommendations for changes and improvements; may include presenting findings for review Design and build complex 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 Independently problem solve and perform root cause analysis for a wide range of engineering activities Characterize and assess design performance against predetermined requirements 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 photocopying or deliveries) What you'll need (Required): Associate's degree or technical degree/certificate and 4+ years of previous experience in an R&D Lab and/or medical device experience - OR – 6+ years of experience in an R&D Lab and/or medical device experience What else we look for (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 Knowledge and understanding of statistical techniques and procedures Ability to utilize CAD/drafting software (if applicable) Knowledge and understanding of ECR software systems (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 in an inter-departmental team environment, as well as with colleagues from other departments and represent organization to outside contacts, i.e., vendors Ability to provide feedback in a professional, direct, and tactful manner 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 $61,000 to $86,000 (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. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Requirements

• Associate's degree or technical degree/certificate and 4+ years of previous experience in an R&D Lab and/or medical device experience - OR – 6+ years of experience in an R&D Lab and/or medical device experience

Nice To Haves

• 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
• Knowledge and understanding of statistical techniques and procedures
• Ability to utilize CAD/drafting software (if applicable)
• Knowledge and understanding of ECR software systems (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 in an inter-departmental team environment, as well as with colleagues from other departments and represent organization to outside contacts, i.e., vendors
• Ability to provide feedback in a professional, direct, and tactful manner
• 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

• Support a wide range of engineering activities such as test, check out, modification, fabrication and assembly; may formulate and propose technical solutions
• Design and 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 all 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
• Generate reports and support recommendations for changes and improvements; may include presenting findings for review
• Design and build complex 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
• Independently problem solve and perform root cause analysis for a wide range of engineering activities
• Characterize and assess design performance against predetermined requirements
• 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 photocopying 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees