2nd Shift Engineer II, Quality - Edwards Lifesciences
Salt Lake City, UT
About the Job
Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you'll make an impact:
+ Investigate moderately 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.
+ Optimize to optimize moderately complex Manufacturing 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.
+ Other incidental duties assigned by Leadership
What we look for (Required):
+ Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related work experience required OR
+ Master's Degree or equivalent with internship, senior projects or thesis in an Engineering or Scientific field required
What else we look for (Preferred):
+ Experience working in a manufacturing environment
+ Experience working in a highly regulated industry, medical device industry experience preferred
+ Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
+ Basic understanding of statistical techniques
+ Previous experience working with lab/industrial equipment
+ Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
+ Solid problem-solving, organizational, analytical and critical thinking skills
+ Solid understanding of processes and equipment used in assigned work
+ 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
+ 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 Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
How you'll make an impact:
+ Investigate moderately 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.
+ Optimize to optimize moderately complex Manufacturing 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.
+ Other incidental duties assigned by Leadership
What we look for (Required):
+ Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related work experience required OR
+ Master's Degree or equivalent with internship, senior projects or thesis in an Engineering or Scientific field required
What else we look for (Preferred):
+ Experience working in a manufacturing environment
+ Experience working in a highly regulated industry, medical device industry experience preferred
+ Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
+ Basic understanding of statistical techniques
+ Previous experience working with lab/industrial equipment
+ Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
+ Solid problem-solving, organizational, analytical and critical thinking skills
+ Solid understanding of processes and equipment used in assigned work
+ 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
+ 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 Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Source : Edwards Lifesciences