Job description
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.The New Product Development (NPD) team is looking for a Technologist to support Transcatheter Heart Valve (THV) projects. This team is responsible for the development of manufacturing and inspection processes for new products (delivery system, sheath, and accessories). The Technologist will work closely with NPD engineers and cross-functional team members to support development of future devices.
Key Responsibilities:
Support a wide range of engineering activities such as testing, troubleshooting, equipment/tooling induction and qualification, data collection and documentation, purchasing, and assembly under minimal supervision of Engineers. May propose technical solutions. Perform complex work using drawings, diagrams, written and verbal instructions, layouts or defined plans.
Perform somewhat complex troubleshooting of standard and custom equipment to identify root causes; propose and implement temporary and/or permanent solutions in collaboration with Engineers.
Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions.
Induct new equipment in Maximo and set up associated preventive maintenance procedures.
Draft and execute Tooling and Fixture Installation Qualifications and Installation Qualifications.
Make tooling, equipment, and supplies purchases.
Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback to engineers on procedures
Create and modify drawings and procedures for fixtures, equipment, products, or processes
Other incidental duties as assigned by Management.
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.
Perform other duties and responsibilities as assigned.
Minimum Qualifications:
Associate's degree with 4 years of experience in R&D Lab and/or manufacturing OR 6 years of previous related experience required
Preferred Qualifications:
Medical device experience is preferred
Strong written and verbal communication
Good interpersonal and relationship building skills
Strong ability to perform complex troubleshooting. Experience with mechanical and electrical system development and troubleshooting preferred.
Ability to identify problems and relevant issues in complex situations, and propose technical solutions
Ability to read and understand procedures, drawings, schematics and carry out assembly instructions
Good computer skills, including usage of MS Office Suite
Use of GDP (Good Documentation Practices)
Substantial understanding of equipment in a lab environment; Ability to use a wider range of manufacturing, test, development or diagnostic equipment.
Strict attention to detail
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
Must be able to work in a team environment, including inter-departmental teams
Must be able to represent organization to outside contacts, i.e., vendors
Ability to provide feedback in a professional, direct, and tactful manner.
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 $57,000 to $80,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
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