Manager Engineering, NPD Quality

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 Manager Engineering, NPD Quality position is a unique career opportunity that could be your next step toward an exciting future.

Imagine how your ideas and expertise can change a patient’s life. Our New Product Development Quality team plays a central role in ensuring our innovative products are delivered to patients with cardiovascular disease. You’ll partner cross‑functionally with R&D, Manufacturing, Clinical Development, and Regulatory teams, delivering thoughtful solutions to complex challenges while expanding your leadership and knowledge of the medical device industry.

• Leading quality engineering new product development strategy and execution to ensure compliance with global regulatory requirements and a strong culture of quality
• Collaborate with global team to support the growth and success of an early‑stage innovative product
• Managing and developing a high‑performing team to strengthen business acumen and functional expertise
• Planning and directing operational and project activities, ensuring successful and timely delivery of key deliverables
• Driving continuous improvement by identifying opportunities and leading implementation of process enhancements
• Overseeing engineering activities and providing technical guidance on complex issues and procedures
• Collaborating cross‑functionally across multiple sites and locations as the quality engineering lead for a new product development program, including design, development, characterization, verification, validation, and monitoring
• Creating and maintaining complex engineering documentation, including design requirements and risk management documents aligned with design control standards
• Analyzing and resolving complex issues requiring deep technical knowledge
• Supporting additional duties as needed

• Bachelor's degree in engineering, scientific or related field with related experience in engineering
• Experience in quality engineering, quality management, and/or regulatory compliance within the medical device industry

• Demonstrating experience within regulated industries and strong knowledge of FDA, GMP, and ISO/EN requirements
• Experience with product development processes, risk management, and usability engineering.
• Hands on experience with valve and delivery system, sheath and/or catheter design, manufacturing processes, and testing.
• Applying advanced statistical and engineering methods, including DOE, SPC, FMEA, process capability, and Lean Manufacturing
• Leading and developing teams, providing coaching, feedback, and full employee management in partnership with HR
• Managing technical or engineering functions while mentoring peers and influencing cross‑functional partners
• Driving successful project execution through strong project management and effective use of metrics
• Applying strong problem‑solving, analytical, and critical thinking skills with sound judgment and discretion
• Communicating effectively, producing high‑quality documentation, and building strong stakeholder relationships
• Defining and standardizing engineering procedures and team operating practices
• Collaborating with internal teams as well as external suppliers, vendors, and customers
• Presenting technical information clearly to gain alignment and drive objectives
• Managing competing priorities and excelling in a fast‑paced, dynamic environment
• Interacting professionally across organizational levels and appropriately escalating issues
• Using Microsoft Office and related systems with a high level of proficiency
• Maintaining strong attention to detail and a high standard of quality
• Building cross‑functional relationships to enable best practice sharing and team effectiveness
• Supporting financial awareness as it relates to quality engineering
• Delivering proactive, responsive service…