Manager Engineering, NPD Quality
Manager Engineering, NPD Quality
Inspired by a passion to improve patient lives, Edwards Lifesciences is seeking a Manager Engineering, NPD Quality to join our dynamic team. This role offers a unique opportunity to contribute to groundbreaking innovations in the medical device industry.
What You Will Do
Lead 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
Manage and develop a high-performing team to strengthen business acumen and functional expertise
Plan and direct operational and project activities, ensuring successful and timely delivery of key deliverables
Drive continuous improvement by identifying opportunities and leading implementation of process enhancements
Oversee engineering activities and provide technical guidance on complex issues and procedures
Collaborate cross-functionally across multiple sites and locations as the quality engineering lead for a new product development program
Create and maintain complex engineering documentation, including design requirements and risk management documents aligned with design control standards
Analyze and resolve complex issues requiring deep technical knowledge
Support additional duties as needed
What We Require
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
What We Prefer
Demonstrated 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
Advanced statistical and engineering methods, including DOE, SPC, FMEA, process capability, and Lean Manufacturing
Leadership and development of teams, providing coaching, feedback, and full employee management in partnership with HR
Project management and effective use of metrics
Strong problem-solving, analytical, and critical thinking skills with sound judgment and discretion
Effective communication, producing high-quality documentation, and building strong stakeholder relationships
Defining and standardizing engineering procedures and team operating practices
Collaboration with internal teams as well as external suppliers, vendors, and customers
Managing competing priorities and excelling in a fast-paced, dynamic environment
Professional interaction across organizational levels and appropriate escalation of issues
Proficiency in Microsoft Office and related systems
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
Proactive, responsive service to meet client and stakeholder needs
Adhering to all company rules and requirements (e.g., Environmental Health & Safety rules)
Benefits
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. For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
COVID-19 Vaccination Requirement
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.