Senior Engineer, Business Excellence

Edwards Lifesciences • Irvine, CA

4d • $108,000 - $153,000

About The Position

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 Senior Engineer, Business Excellence position is a unique career opportunity that could be your next step towards an exciting future. Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives. How you will make an impact: Join Edwards Lifesciences’ Pilot Operations team as a Senior Engineer, helping shape the development and implementation of the team’s mission and vision while supporting new and evolving manufacturing processes. Lead operational and business excellence initiatives within Pilot manufacturing environments, driving measurable improvements in safety, quality, delivery, cost, and compliance using Lean, Six Sigma, and structured problem‑solving methodologies. Identify, prioritize, and execute continuous improvement opportunities through tools such as value stream mapping, cycle‑time optimization, waste elimination, line balancing, standard work, SMED, pull systems, TPM, and 6S, while navigating ambiguity in fast‑changing Pilot settings. Define clear problem statements, facilitate root cause analysis (A3, Kaizen, and related methods), and ensure corrective and preventive actions are implemented, sustained, and monitored over time. Develop and maintain KPIs, dashboards, tiered operating reviews, and digital tools that increase visibility, support fact‑based decision‑making, and improve performance at all organizational levels. Partner closely with engineering, manufacturing, supply chain, quality, and corporate Business Excellence teams across sites to align improvement initiatives with business strategy, regulatory commitments, and manufacturing priorities. Lead change adoption through effective communication, training, coaching, and stakeholder engagement to ensure improvements are understood and sustained. Define, document, and govern standard work, operating procedures, and knowledge‑transfer practices to ensure consistency, sustainability, and compliance across Pilot teams. Coach and mentor technicians, technologists, and engineers in Lean fundamentals and problem‑solving tools, supporting Yellow Belt and Green Belt development through training, Kaizen events, and hands-on line transformations. Lead improvement programs and projects with clear milestones, risk management, escalation paths, and measurable business results, delivering impact without introducing compliance or safety risk. Ensure all improvement activities align with EHS, Quality, regulatory, and Edwards compliance requirements while maintaining a strong culture of safety and quality. Provide clear, data‑driven updates to leadership on progress, risks, outcomes, and recommendations through structured reviews and standardized reporting. Perform other duties and responsibilities as assigned.

Requirements

• A Bachelor's degree in Engineering or Scientific field with 4 years of previously related industry experience OR Master’s degree in Engineering or Scientific field with 3 years of previously related industry experience Required

Nice To Haves

• Lean practitioner and certification(s).
• Six Sigma related certifications are a plus.
• Class II and Class III medical device manufacturing experience is a plus.
• Applies engineering methods (e.g., Six Sigma and LEAN methods) for problem solving and continuous process improvement.
• Highly Proficient in Microsoft Office suites including Access, Excel, Word and PowerPoint.
• Demonstrated use of Design for Manufacturability, Industrial Engineering and lean experience leading to manufacturing efficiency improvement.
• Knowledge of cGMP, EHS guidelines, FDA guidelines, QSR, FMEA, statistical techniques, Supplier Quality and Process Validation (IQ, OQ, PQ and PPQ).
• Interpersonal skills including problem solving, effective communication, conflict and relationship management.
• Solid project management and team leadership skills leading to substantial cost savings.
• Self-motivated with tangible solid contribution, a calculated assertive risk taker and change agent.
• Demonstrated commitment to Edwards values, EHS standards, and ethical business practices.

Responsibilities

• Join Edwards Lifesciences’ Pilot Operations team as a Senior Engineer, helping shape the development and implementation of the team’s mission and vision while supporting new and evolving manufacturing processes.
• Lead operational and business excellence initiatives within Pilot manufacturing environments, driving measurable improvements in safety, quality, delivery, cost, and compliance using Lean, Six Sigma, and structured problem‑solving methodologies.
• Identify, prioritize, and execute continuous improvement opportunities through tools such as value stream mapping, cycle‑time optimization, waste elimination, line balancing, standard work, SMED, pull systems, TPM, and 6S, while navigating ambiguity in fast‑changing Pilot settings.
• Define clear problem statements, facilitate root cause analysis (A3, Kaizen, and related methods), and ensure corrective and preventive actions are implemented, sustained, and monitored over time.
• Develop and maintain KPIs, dashboards, tiered operating reviews, and digital tools that increase visibility, support fact‑based decision‑making, and improve performance at all organizational levels.
• Partner closely with engineering, manufacturing, supply chain, quality, and corporate Business Excellence teams across sites to align improvement initiatives with business strategy, regulatory commitments, and manufacturing priorities.
• Lead change adoption through effective communication, training, coaching, and stakeholder engagement to ensure improvements are understood and sustained.
• Define, document, and govern standard work, operating procedures, and knowledge‑transfer practices to ensure consistency, sustainability, and compliance across Pilot teams.
• Coach and mentor technicians, technologists, and engineers in Lean fundamentals and problem‑solving tools, supporting Yellow Belt and Green Belt development through training, Kaizen events, and hands-on line transformations.
• Lead improvement programs and projects with clear milestones, risk management, escalation paths, and measurable business results, delivering impact without introducing compliance or safety risk.
• Ensure all improvement activities align with EHS, Quality, regulatory, and Edwards compliance requirements while maintaining a strong culture of safety and quality.
• Provide clear, data‑driven updates to leadership on progress, risks, outcomes, and recommendations through structured reviews and standardized reporting.
• Perform other duties and responsibilities as assigned.

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees