Principal Engineer, Metals CoE - Advanced Technology Job at Edwards Lifesciences
Edwards Lifesciences Irvine, CA
$106,000 - $151,000 a year
Represent the Metals Center of Excellence (MCoE) team in engaging with internal R&D teams by providing technical project management of metal component manufacturing (equipment and process development) through close collaboration with the Metals CoE Process team.
Key Responsibilities:
Provide technical communication to project teams and ensure that objectives and timelines are met for each project. Create and maintain good relationships and collaboration with partners in various business units by understanding their needs, development plans and testing. Organize and prioritize various project efforts and communicate to the Process, Prototype and Pilot teams within the Metals CoE.
Conceptualize, design, and develop complex components, tooling, equipment, and processes for class III implantable devices. This includes rapid prototyping, design, development of equipment and processes for metals manufacturing, project team support, and interfacing with key external suppliers.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Assist design selection based on clinical impact, material, and supplier manufacturability. Assist development of test methods and procedures to evaluate prototype performance.
Interface with Manufacturing, R&D, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and external policies and procedures (Quality System Regulation, FDA Regulations, and ISO Standards).
Expand knowledge of nitinol and other metals processing techniques through training, attending conferences and learning from both internal and external teams.
Education and Experience:
Bachelor’s degree in mechanical, biomedical or a related engineering discipline with a minimum of 6 years of experience in related field or
Master’s degree in mechanical, biomedical or a related engineering discipline with a minimum of 5 years of experience in related field or
Ph. D. in mechanical, biomedical or a related engineering discipline with a minimum of 2 years of experience in related field
Additional Skills:
Proven track record in technical leadership and communication to internal and external clients.
Experience and knowledge of metal material properties is required.
Experience in metal manufacturing techniques (machining, laser cutting, chemical polishing, etc.) is required.
Design for manufacturing (DFM), mechanical design and drawing interpretation experience is required.
Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development is required.
Proven expertise in usage of MS Office Suite is required.
Experience in the medical device industry is preferred.
CAD (SolidWorks or Creo Parametric) experience is preferred.
Proven ability to apply technical knowledge and judgment to complex engineering problems.
Ability to work well independently and as a member of a team is essential.
Strong problem-solving skillset, the ability to rapidly iterate and react to customer feedback, and act as a mentor to junior engineers.
Clinical and anatomical knowledge with an ability to communicate with collaborating R&D engineers is preferred.
Experience in metals analytical testing (DSC, metallography, SEM, corrosion, Auger) is preferred.
Six Sigma Black Belt is preferred.
Preferred background includes experience in more than one of the following areas: Nitinol manufacturing, metallic implant manufacturing, rapid product development, electrochemistry, metals 3D printing, metals machining, process development, statistics, and mechanical component design.
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 $106,000 to $151,000(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 :
www.epokagency.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, www.epokagency.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.
Key Responsibilities:
Provide technical communication to project teams and ensure that objectives and timelines are met for each project. Create and maintain good relationships and collaboration with partners in various business units by understanding their needs, development plans and testing. Organize and prioritize various project efforts and communicate to the Process, Prototype and Pilot teams within the Metals CoE.
Conceptualize, design, and develop complex components, tooling, equipment, and processes for class III implantable devices. This includes rapid prototyping, design, development of equipment and processes for metals manufacturing, project team support, and interfacing with key external suppliers.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Assist design selection based on clinical impact, material, and supplier manufacturability. Assist development of test methods and procedures to evaluate prototype performance.
Interface with Manufacturing, R&D, Clinical Affairs, Quality, Marketing, outside consultants, and vendors/suppliers, to ensure compliance with internal and external policies and procedures (Quality System Regulation, FDA Regulations, and ISO Standards).
Expand knowledge of nitinol and other metals processing techniques through training, attending conferences and learning from both internal and external teams.
Education and Experience:
Bachelor’s degree in mechanical, biomedical or a related engineering discipline with a minimum of 6 years of experience in related field or
Master’s degree in mechanical, biomedical or a related engineering discipline with a minimum of 5 years of experience in related field or
Ph. D. in mechanical, biomedical or a related engineering discipline with a minimum of 2 years of experience in related field
Additional Skills:
Proven track record in technical leadership and communication to internal and external clients.
Experience and knowledge of metal material properties is required.
Experience in metal manufacturing techniques (machining, laser cutting, chemical polishing, etc.) is required.
Design for manufacturing (DFM), mechanical design and drawing interpretation experience is required.
Experience with rapid product development in cross-functional teams, creative design, prototyping, and test method development is required.
Proven expertise in usage of MS Office Suite is required.
Experience in the medical device industry is preferred.
CAD (SolidWorks or Creo Parametric) experience is preferred.
Proven ability to apply technical knowledge and judgment to complex engineering problems.
Ability to work well independently and as a member of a team is essential.
Strong problem-solving skillset, the ability to rapidly iterate and react to customer feedback, and act as a mentor to junior engineers.
Clinical and anatomical knowledge with an ability to communicate with collaborating R&D engineers is preferred.
Experience in metals analytical testing (DSC, metallography, SEM, corrosion, Auger) is preferred.
Six Sigma Black Belt is preferred.
Preferred background includes experience in more than one of the following areas: Nitinol manufacturing, metallic implant manufacturing, rapid product development, electrochemistry, metals 3D printing, metals machining, process development, statistics, and mechanical component design.
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 $106,000 to $151,000(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 :
www.epokagency.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, www.epokagency.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.