Manager Engineering, NPD Quality

Edwards Lifesciences • Irvine, CA

1d • $121,000 - $171,000

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 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.

Requirements

• 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

Nice To Haves

• 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 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 to meet client and stakeholder needs
• Adhere to all company rules and requirements (e.g., 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

Responsibilities

• Leading quality engineering new product development strategy and execution to ensure compliance with global regulatory requirements and a strong culture of quality
• 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 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

Benefits

• competitive salaries
• performance-based incentives
• 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: Manager