Job Description
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.
This Quality Engineer II will support a Metals project through the development phase and into manufacturing production. They will contribute to process development and execution of design verification and validation activities as well as support the transition of the project to manufacturing and stabilize the line through knowledge of lean principles, root cause investigations, and driving yield improvement. In addition, they will support supplier and receiving inspection related activities.
How you'll make an impact:
Develop moderately 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.
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
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production
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 you'll need (Required):
Bachelor's Degree in an Engineering or Scientific field, with at least 2 years of previous related work experience OR
Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for (Preferred):
Previous experience with R&D, quality engineering, and/or developing inspection routines
Experience with Metals processing development with the medical device industry
Experience with welding and/or laser welding
Experience with lean manufacturing
Experience supporting transfers from New Product Development to Production
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 manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
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.
This Quality Engineer II will support a Metals project through the development phase and into manufacturing production. They will contribute to process development and execution of design verification and validation activities as well as support the transition of the project to manufacturing and stabilize the line through knowledge of lean principles, root cause investigations, and driving yield improvement. In addition, they will support supplier and receiving inspection related activities.
How you'll make an impact:
Develop moderately 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.
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
Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production
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 you'll need (Required):
Bachelor's Degree in an Engineering or Scientific field, with at least 2 years of previous related work experience OR
Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for (Preferred):
Previous experience with R&D, quality engineering, and/or developing inspection routines
Experience with Metals processing development with the medical device industry
Experience with welding and/or laser welding
Experience with lean manufacturing
Experience supporting transfers from New Product Development to Production
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 manage competing priorities in a fast paced environment
Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
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.
Key skill Required
- Manufacturing
- Affirmative Action
- Attention to Detail
- Audit
- Communication
- Compliance
- Continuous Process
- Critical Thinking
- Design
- Design For Manufacturing
- Development
- Documentation
- Environmental
- Environmental Health
- Healthcare
- Influence
- Innovation
- Interpersonal Relationship
- Knowledge Transfer
- Leadership
- Lean Manufacturing
- Management
- Medical Device
- Medical Device Industry
- Negotiating
- Problem Solving
- Process Development
- Process Improvement
- Product Development
- Product Quality
- Quality Engineering
- Receiving
- Receiving Inspection
- Relationship Skills
- Risk Management
- Six Sigma
- Training
- Vaccination
- Validation
- Verification and Validation
- Welding
- Work Instructions
- Writing
