Quality Engineer I, NPD

Edwards Lifesciences; Salt Lake City (UT); On-site; USD 65,000 - 95,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City, UT seeks a Manufacturing/Quality Engineer to optimize manufacturing processes and support design control activities. You will develop process documentation and training materials for production, collaborate on process controls, and assist in root cause investigations before commercialization.

The role emphasizes basic experiments, validations (IQ/OQ/Software), and equipment/ tooling design support, with a focus on LEAN improvements and cross-functional

Qualifications

• Bachelor's Degree in Engineering or Scientific field required.
• Strong problem-solving and analytical abilities.
• Experience with manufacturing/QA processes helpful.

Responsibilities

• Support design control activities related to manufacturing product and process.
• Develop documentation related to manufacturing (drawings, SOPs, routers, pFMEA).
• Create basic training and documentation materials for production.
• Support development of process definitions and process controls.
• Collaborate on root cause investigations for manufacturing processes before commercialization.
• Assist in qualification and validation (IQ, OQ, Software) of manufacturing processes.
• Provide technical support in process transfer and equipment enhancements.
• Identify opportunities to improve manufacturing processes using LEAN/methods.
• Perform basic experiments and tests to characterize processes.

Skills

Problem solving

Analytical thinking

Organizational skills

Critical thinking

Teamwork

Education

Bachelor's Degree in Engineering or Scientific field

Tools

CAD

MS Project

MS Office

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. 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. In this role, you will apply your knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

How you will make an impact:

• Support design control activities related to manufacturing product and process.

Develop documentation related to manufacturing (i.e., drawings, SOP, routers, pFMEA) at various levels of release. Develop basic training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes

• Support creation of process definition / development of process controls.
• Support specifications from an operations perspective (i.e., DFx, tolerancing, material selection, automation) supporting the establishment of stability metrics and elevating / mitigating risks through SCRR, MRR
• Collaborate build strategy, prioritization, and build technical support for QST, pre DV, DV - Partner with Pilot on root cause investigations for manufacturing processes (prior to commercialization)
• Support development of basic experiments and tests (including writing and executing protocols) to characterize and develop processes. Support qualifications and validations (IQ, OQ, Software) of manufacturing processes.
• Support manufacturing equipment engineering and tooling design (Program Specific)
• Collaborate in the analysis of basic Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations) and provide technical support in process transfer.
• Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes
• Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement
• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field

What else we look for (Preferred):

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment preferred (if applicable)
• Good understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Good problem-solving, organizational, analytical and critical thinking skills
• Good understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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 immediate supervisor and other team members in the section or group; and may interact with vendors
• Ability to build stable working relationships internally
• 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.