Senior Engineer, Supplier Quality
Edwards Lifesciences is seeking a Senior Engineer to join our New Product Development team at our Draper, Utah site! This engineer will support component engineering, supplier management, and various projects providing quality engineering expertise and working closely with suppliers to ensure that the product received meets requirements and specifications.
Key
Responsibilities:
Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
Investigate complex manufacturing product quality and compliance issues (e.
g.
, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.
g.
, SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc.
to improve manufacturing processes, and reduce risk.
Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.
g.
, work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train, coach, and guide lower level employees on routine procedures Other incidental duties assigned by Leadership Required
Qualifications:
Bachelor's Degree in an Engineering or Scientific field with at least 4 years of previous related experience, including either industry or industry/education Required or Master's Degree or equivalent in an Engineering or Scientific field with at least 3 years of previous related experience, including either industry or industry/education Required or Ph.
D.
or equivalent in an Engineering or Scientific field with 0 years of prevous related experience Required Preferred
Qualifications:
Experience working in a regulated industry Proven ability to manage larger scale projects Experience working with suppliers Experience reporting to leadership, doing presentations, and managing timelines Proven expertise in usage of MS Office Suite; CAD experience Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Working knowledge and understanding of statistical techniques Previous experience working with lab/industrial equipment required Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects 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 environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination RequirementEdwards 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.
Recommended Skills Analytical Attention To Detail Auditing Business Relationship Management Cad Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
Key
Responsibilities:
Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
Investigate complex manufacturing product quality and compliance issues (e.
g.
, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.
g.
, SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc.
to improve manufacturing processes, and reduce risk.
Develop, update, and maintain technical content of risk management files Develop training and documentation materials for production (e.
g.
, work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train, coach, and guide lower level employees on routine procedures Other incidental duties assigned by Leadership Required
Qualifications:
Bachelor's Degree in an Engineering or Scientific field with at least 4 years of previous related experience, including either industry or industry/education Required or Master's Degree or equivalent in an Engineering or Scientific field with at least 3 years of previous related experience, including either industry or industry/education Required or Ph.
D.
or equivalent in an Engineering or Scientific field with 0 years of prevous related experience Required Preferred
Qualifications:
Experience working in a regulated industry Proven ability to manage larger scale projects Experience working with suppliers Experience reporting to leadership, doing presentations, and managing timelines Proven expertise in usage of MS Office Suite; CAD experience Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Working knowledge and understanding of statistical techniques Previous experience working with lab/industrial equipment required Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Quality systems Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects 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 environment and prevention of pollution under their span of influence/control Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination RequirementEdwards 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.
Recommended Skills Analytical Attention To Detail Auditing Business Relationship Management Cad Coaching And Mentoring Estimated Salary: $20 to $28 per hour based on qualifications.
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