Quality Engineer Ii Jobs

This is an exciting opportunity for a Quality Engineer to join our Advanced Catheters team at our Draper, Utah site. They will support a line transfer from our Irvine site to our Draper plant by doing qualifications and validations as well as trials runs for product builds.
Key Responsibilities:

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• 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
• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
• 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.
• Other incidental duties assigned by Leadership
• Develop, update, and maintain technical content of risk management files

Required Qualifications:

• Master's Degree or equivalent in and internship, senior projects or thesis in an Engineering or Scientific field including either industry or industry/education Required
• Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related work experience Required or

Preferred Qualifications:

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Experience with equipment, process, and tooling fixture validations
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Strict attention to detail
• Ability to manage competing priorities in a fast paced 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
• Experience with test method validations
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Experience supporting a line transfer
• Solid problem-solving, organizational, analytical and critical thinking skills
• Previous experience working with lab/industrial equipment
• Ability to interact professionally with all organizational levels
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Experience writing protocols and reports
• Experience with design control and FMEA

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.