Manufacturing Quality Engineer II, Sustaining; 2nd Shift

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Quality Engineer II position is a unique career opportunity that could be your next step towards an exciting future.

• Investigate moderately complex manufacturing product quality and compliance issues, including investigating PRAs and complaints for manufacturing related issues.
• Manage site NCRs, CAPAs, ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results.
• Provide technical support to external and internal audits, make recommendations and develop reports.
• Oversee product release, assess and disposition product on hold (MRB), and manage material quality control.
• Review and approve equipment validations and asset management actions.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., Six Sigma, TPP, and Lean methods) for design for manufacturing and continuous process improvement.
• Identify opportunities for re‑design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk.
• Collaborate with engineering teams to ensure successful transfers.
• Develop training and documentation materials for production (e.g., work instructions) to enable seamless knowledge transfer of project and manufacturing processes.
• Provide support for Process Validation or lead TMVS, Sustaining Quality Engineering responsibilities such as review of Quality Metrics, Material Review Boards, Quality Control, etc.
• Assign support tasks, give instruction to technicians on conducting tests, train technicians, provide feedback, and coordinate technician work.

• Bachelor’s degree in engineering or a scientific field with 2 years of experience in Quality Engineering, Manufacturing Engineering, Process Engineering, or related experience in a regulated manufacturing environment; OR
• Master’s degree in engineering or scientific field with no experience (or internship/co‑op experience).
• Experience owning NCRs and CAPAs.
• Ability to work onsite (100%) during the designated 2nd‑shift schedule (Monday – Thursday, 3:30 PM – 2:30 AM).

• Engineering degree.
• Highly regulated manufacturing environment experience (medical device highly preferred).
• Experience supporting manufacturing operations, production processes, or sustaining engineering activities.
• Experience investigating and resolving quality issues through structured problem‑solving methodologies.
• Strong understanding of MRB processes, quality metrics, and continuous improvement methodologies.
• Familiarity with Manufacturing Execution Systems (MES).
• Hands‑on involvement with precision machining environments, including CNC and Swiss machining operations.
• Proficiency with Keyence inspection systems, vision systems, or automated inspection technologies.
• Background supporting new product introduction (NPI), manufacturing transfers, product launches, and production stabilization.
• Working knowledge of process validation activities, including IQ/OQ/PQ and manufacturing process controls.
• Understanding of SPC, pFMEA, risk management, root cause analysis, and statistical problem‑solving techniques.
• Knowledge of Lean Manufacturing, Six Sigma, and continuous improvement tools.
• Demonstrated ability to collaborate effectively with Operations, Manufacturing Engineering, Quality Control, and cross‑functional stakeholders.
• Familiarity with FDA Quality System Regulations, ISO 13485, and regulated manufacturing quality systems.

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

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. 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.