Location
USA - California – Irvine
Compensation
$121k–$171k USD
Posted
Yesterday
Market range · function + seniority
p25 · target · p75 · n=473
Posted $171k · well below market
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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.
You Will Make an Impact By:
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
What You’ll Need (Required):
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 Else We Look For (Preferred):
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
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.
For California, the base pay range for this position is $121,000 - $171,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, 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.
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