Quality Engineer II - Process Engineering

Edwards Lifesciences; Salt Lake City (UT); On-site; USD 90,000 - 130,000; Full time

Job summary

Edwards Lifesciences in Salt Lake City seeks a Quality Engineer II to support the PASCAL Gen 3 product line at the Draper facility, partnering with manufacturing, supplier quality, and cross-functional engineering teams to stabilize a new product line, improve yield, resolve quality issues, and help prepare for future launches.

You will work to ensure commercially released and human-use products meet rigorous quality expectations while directly impacting patients worldwide.

Qualifications

• Bachelor's degree in engineering or scientific field with 2 years Quality or Manufacturing Engineering experience preferred.
• Experience supporting production line sustaining activities.
• Experience in a highly regulated industry such as medical device, aerospace, automotive, semiconductor, or similar.

Responsibilities

• Support sustaining Quality Engineering activities for the PASCAL Gen 3 line, including stabilization and continuous improvement.
• Partner with cross-functional teams to identify quality trends and drive yield improvements.
• Own or support NCRs, investigations, dispositions, containment, and corrective actions per quality system requirements.
• Develop and review engineering studies, test method validations, and manufacturing process validation deliverables.
• Create and sustain dimensional inspection routines using Keyence or similar technology.

Skills

Quality Engineering

Manufacturing Engineering

Data analysis

Problem solving

Documentation

Education

Bachelor's degree in engineering or scientific field

Master's degree in engineering or scientific field

Tools

Keyence programming

TMV / OQ/PQ protocol tools

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.

The Quality Engineer II will support the PASCAL Gen 3 product line at our Draper facility, partnering closely with manufacturing, supplier quality, and cross-functional engineering teams to stabilize a new product line, improve yield, resolve quality issues, and help prepare for future product launches. Your work will help ensure commercially released and human-use products continue to meet rigorous quality expectations while directly impacting patients around the world. The Quality Engineer II will also be a part of next-generation process development.

You will make an impact by:

• Supporting sustaining Quality Engineering activities for the PASCAL Gen 3 product line, including stabilization of a new product line, commercial part number support, and continuous improvement of manufacturing quality performance.
• Utilizing learnings from current generation sustaining to develop and launch the next generation PASCAL products
• Partnering with Manufacturing Engineering, Supplier Quality Engineering, Operations, and other cross‑functional partners to identify quality trends, improve yield, and drive metrics‑based improvements across the production line.
• Owning or supporting nonconformance activities, including NCR authoring, investigations, dispositions, containment, corrective actions, NCR reductions, and related documentation in accordance with quality system requirements.
• Developing, executing, reviewing, and approving engineering studies, test method validations, and manufacturing process validation deliverables, with emphasis on TMVs and OQ/PQ protocol and report review.
• Creating, optimizing, and sustaining dimensional inspection routines, including Keyence programming or similar optical/automated inspection methods used to support manufacturing and human‑use product requirements.
• Applying engineering and quality tools such as root cause analysis, risk assessment, FMEAs, statistical methods, Lean/Six Sigma, and structured problem solving to improve process capability and reduce manufacturing risk.
• Providing technical feedback to supplier quality partners regarding supplier‑related quality issues, inspection approaches, material performance, and opportunities to improve incoming or in‑process quality.
• Developing, updating, and maintaining technical documentation, work instructions, validation documentation, risk documentation, and training materials to ensure effective production support and knowledge transfer.
• Collaborating with technicians, inspectors, engineers, and production teams by assigning support tasks, providing technical guidance, reviewing test work, and helping reinforce quality expectations on the manufacturing floor.

What you’ll need (Required):

• Bachelor's degree in engineering or scientific field with two (2) years of Quality Engineering or Manufacturing Engineering experience in a production, manufacturing, or operations environment; OR Master's degree in engineering or scientific field with no experience (or applicable internship/co-op experience).
• Experience supporting production line sustaining activities.
• Experience working in a highly regulated industry such as medical device, aerospace, automotive, semiconductor, or a similarly regulated manufacturing environment.

What else we look for (Preferred):

• Medical device industry experience.
• Hands‑on NCR authoring experience, including investigation, disposition, root cause analysis, corrective action, and documentation closure.
• Keyence programming experience or experience creating/sustaining optical dimensional inspection routines using similar automated inspection technology.
• Experience with process validations and test method validations, including protocol execution, report writing, and review of Test Method Validation and OQ/PQ documentation.
• Experience with FMEAs, risk management documentation, root cause analysis, CAPA support, investigations, and quality improvement initiatives.
• Working knowledge of quality systems, manufacturing documentation, engineering change control, investigations, and compliance expectations.
• Ability to use data, metrics, and statistical techniques to identify trends, improve yield, reduce defects, and support manufacturing decision‑making.
• Strong documentation, communication, and interpersonal skills with the ability to partner effectively across cross‑functional teams.
• Strong problem‑solving, organizational, analytical, and critical thinking skills with strict attention to detail.
• Ability to manage competing