Senior Manufacturing Engineer Job at Edwards Lifesciences
This is an exciting opportunity to join a fast-paced team at Edwards Lifesciences and play a critical role in developing and improving the manufacturing processes for a novel transcatheter mitral valve replacement system. This role is at the intersection of manufacturing operations and new product development. You will partner with manufacturing, quality, and R&D to drive continuous improvement projects across multiple manufacturing lines, instill design for manufacturing (DFM) principles into the design and development of next generation devices, take ownership over process improvement projects, and collaborate across functions to set the program up for successful long-term production.
Key Responsibilities:
Drive the identification, prioritization, and implementation of process and capacity improvement opportunities across multiple product lines
Collaborate with device owners to conduct investigations, brainstorm improvements, and implement solutions
Apply Six Sigma, Lean, and DFM principles to drive meaningful changes to existing and future manufacturing processes
Create manufacturing processes for new designs and instill a continuous improvement and DFM mindset into the new product development process
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes
Develop training and documentation materials (e.g. work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Establish and lead project plans to ensure deliverables are driven to completion
Oversee manufacturing support tasks by giving instruction to technicians on conducting tests, training technicians and providing feedback, and coordinating technician work
Required Qualifications:
Bachelor's degree in engineering or scientific field with 4 years of previous work experience required or
Master's degree or equivalent in an engineering or scientific field with 3 years previous work experience required or
Ph.D. or equivalent in an engineering or scientific field
Preferred Qualifications:
Proven expertise in Microsoft Office applications; CAD and MS Project experience
Strong problem-solving, organizational, analytical and critical thinking skills
Strong documentation, communication, and interpersonal relationship skills
Substantial understanding and knowledge of principles, theories, and concepts relevant to engineering
Good leadership skills and ability to influence change
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including interdepartmental teams, and be a key contact representing the organization on projects
Basic understanding of statistical techniques
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to interact professionally with all levels of the organization
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 the environment and prevention of pollution under their span of influence/control
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 :
bankofmontserrat.ms 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, bankofmontserrat.ms 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:
Drive the identification, prioritization, and implementation of process and capacity improvement opportunities across multiple product lines
Collaborate with device owners to conduct investigations, brainstorm improvements, and implement solutions
Apply Six Sigma, Lean, and DFM principles to drive meaningful changes to existing and future manufacturing processes
Create manufacturing processes for new designs and instill a continuous improvement and DFM mindset into the new product development process
Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes
Develop training and documentation materials (e.g. work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
Establish and lead project plans to ensure deliverables are driven to completion
Oversee manufacturing support tasks by giving instruction to technicians on conducting tests, training technicians and providing feedback, and coordinating technician work
Required Qualifications:
Bachelor's degree in engineering or scientific field with 4 years of previous work experience required or
Master's degree or equivalent in an engineering or scientific field with 3 years previous work experience required or
Ph.D. or equivalent in an engineering or scientific field
Preferred Qualifications:
Proven expertise in Microsoft Office applications; CAD and MS Project experience
Strong problem-solving, organizational, analytical and critical thinking skills
Strong documentation, communication, and interpersonal relationship skills
Substantial understanding and knowledge of principles, theories, and concepts relevant to engineering
Good leadership skills and ability to influence change
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including interdepartmental teams, and be a key contact representing the organization on projects
Basic understanding of statistical techniques
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to medical device manufacturing
Knowledge of applicable FDA regulations for medical device industry
Strict attention to detail
Ability to interact professionally with all levels of the organization
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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 the environment and prevention of pollution under their span of influence/control
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 :
bankofmontserrat.ms 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, bankofmontserrat.ms 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.