Senior Chemist Job at Edwards Lifesciences
Summary
The Edwards Quality Labs (EQL) provides a comprehensive range of testing and consulting services for safety and biocompatibility evaluation of medical devices. This business segment has an rare opening for an experienced scientist with a background in Chemistry, Chemical Engineering, Materials Science, or Polymer Chemistry with expertise in the medical device industry to join a high impact and dynamic team in a chemistry study director role.
The Chemistry Study Director (Sr Chemist) manages and executes all chemistry testing for new and in-process products, including extractables and leachables chemical characterization (ISO 10993-18), ethylene oxide residuals (ISO 10993-7), cleaning validations, targeted chemical residual analysis, and nontargeted screening analysis, among others. The study director may or may not directly perform analytical work but is responsible for the study protocol, oversight of the study, the final report, and resolution of any deviations.
Will cross function with a diverse team ranging from analytical chemists, biologists, toxicologists, engineers, and management. This is an excellent opportunity to work in leading medical device company developing life-saving products and with possibilities for growth.
Essential Job Functions:
Apply chemistry knowledge and concepts to write and approve protocols, reports, out of specification (OOS) documents, technical summaries, procedures, and gap assessments in collaboration with inter‐departmental teams.
Work closely with business units to review surface area requirements for devices requiring testing and collaborate on creating device testing instructions.
Interpret data and define qualification strategies for new or modified devices and/or processes. Collaborate with project teams to assist in establishing testing recommendations per biocompatibility guidelines defined in International Organization for Standardization (ISO) 10993 chapters.
Investigate and perform corrective and preventative actions (CAPA) testing and propose solutions and recommendations for improvement.
Make recommendations and validate new laboratory equipment—e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ)— as required.
Lead smaller process improvement projects and propose recommendations for manager approval.
Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures.
Providing consulting support on questions of chemical test strategy for various polymeric and metallic products, coatings, polymer additives, pigments/dyes, surface treatment agents, surfactants, solvents, processing aids, etc.
Other incidental duties assigned by leadership.
Required Qualifications
Bachelor's Degree in Chemistry, Chemical Engineering, Materials Science, Polymer Chemistry, or related field plus minimum of 4 years of relative experience required
Master's Degree in relative field plus minimum 2 years of experience required; PhD in relative field plus minimum of 1 year of experience required
Experience in the medical device or pharmaceutical industry (or relevant university experience) required
Other Skills and Experience
Substantial knowledge and understanding of chemical principles, theories, and concepts.
Knowledge of common analytical chemistry laboratory equipment (e.g. gas chromatography, high performance liquid chromatography, inductively coupled plasma, mass spectrometry, total organic carbon, Fourier transform infrared spectroscopy, etc) and ability to critically interpret test methods and generated data.
Knowledge of common medical device materials and manufacturing processing aids, including types of polymer additives and compounded formulations. Knowledge of common medical device manufacturing techniques (e.g. extrusion, injection molding, machining), as well as cleaning and sterilization processes.
Knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, ASTM, FDA)
Knowledge of Good Laboratory Practices, Good Manufacturing Practices, and Good Documentation Practices supporting a medical device quality environment (ISO 13485).
Ability to manage competing priorities and multiple projects in a fast-paced environment. Ability to work independently on more complex projects and/or lines of work and review for accuracy and soundness.
Excellent facilitation, presentation, and written communication skills.
Able to thrive in a collaborative team environment, including interdepartmental teams and representing the organization on specific projects.
Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) and Adobe PDF tools
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines—ability to 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$86,000to$121,000(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.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
clarksqn.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, clarksqn.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
The Edwards Quality Labs (EQL) provides a comprehensive range of testing and consulting services for safety and biocompatibility evaluation of medical devices. This business segment has an rare opening for an experienced scientist with a background in Chemistry, Chemical Engineering, Materials Science, or Polymer Chemistry with expertise in the medical device industry to join a high impact and dynamic team in a chemistry study director role.
The Chemistry Study Director (Sr Chemist) manages and executes all chemistry testing for new and in-process products, including extractables and leachables chemical characterization (ISO 10993-18), ethylene oxide residuals (ISO 10993-7), cleaning validations, targeted chemical residual analysis, and nontargeted screening analysis, among others. The study director may or may not directly perform analytical work but is responsible for the study protocol, oversight of the study, the final report, and resolution of any deviations.
Will cross function with a diverse team ranging from analytical chemists, biologists, toxicologists, engineers, and management. This is an excellent opportunity to work in leading medical device company developing life-saving products and with possibilities for growth.
Essential Job Functions:
Apply chemistry knowledge and concepts to write and approve protocols, reports, out of specification (OOS) documents, technical summaries, procedures, and gap assessments in collaboration with inter‐departmental teams.
Work closely with business units to review surface area requirements for devices requiring testing and collaborate on creating device testing instructions.
Interpret data and define qualification strategies for new or modified devices and/or processes. Collaborate with project teams to assist in establishing testing recommendations per biocompatibility guidelines defined in International Organization for Standardization (ISO) 10993 chapters.
Investigate and perform corrective and preventative actions (CAPA) testing and propose solutions and recommendations for improvement.
Make recommendations and validate new laboratory equipment—e.g., Installation Qualification, Operational Qualification (IQOQ), and Performance Qualification (PQ)— as required.
Lead smaller process improvement projects and propose recommendations for manager approval.
Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback on procedures.
Providing consulting support on questions of chemical test strategy for various polymeric and metallic products, coatings, polymer additives, pigments/dyes, surface treatment agents, surfactants, solvents, processing aids, etc.
Other incidental duties assigned by leadership.
Required Qualifications
Bachelor's Degree in Chemistry, Chemical Engineering, Materials Science, Polymer Chemistry, or related field plus minimum of 4 years of relative experience required
Master's Degree in relative field plus minimum 2 years of experience required; PhD in relative field plus minimum of 1 year of experience required
Experience in the medical device or pharmaceutical industry (or relevant university experience) required
Other Skills and Experience
Substantial knowledge and understanding of chemical principles, theories, and concepts.
Knowledge of common analytical chemistry laboratory equipment (e.g. gas chromatography, high performance liquid chromatography, inductively coupled plasma, mass spectrometry, total organic carbon, Fourier transform infrared spectroscopy, etc) and ability to critically interpret test methods and generated data.
Knowledge of common medical device materials and manufacturing processing aids, including types of polymer additives and compounded formulations. Knowledge of common medical device manufacturing techniques (e.g. extrusion, injection molding, machining), as well as cleaning and sterilization processes.
Knowledge in the review, evaluation, interpretation, and implementation of internal and external guidance's (e.g., ISO, ASTM, FDA)
Knowledge of Good Laboratory Practices, Good Manufacturing Practices, and Good Documentation Practices supporting a medical device quality environment (ISO 13485).
Ability to manage competing priorities and multiple projects in a fast-paced environment. Ability to work independently on more complex projects and/or lines of work and review for accuracy and soundness.
Excellent facilitation, presentation, and written communication skills.
Able to thrive in a collaborative team environment, including interdepartmental teams and representing the organization on specific projects.
Advanced proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint) and Adobe PDF tools
Knowledge of and adherence to Environmental Health and Safety and Quality guidelines—ability to 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$86,000to$121,000(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.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Please Note :
clarksqn.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, clarksqn.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.