Principal Quality Engineer, Change Management & Technical Writing

*Please note that this is an "onsite" role, and the successful candidate will be expected to work from our corporate Irvine, CA campus.

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. 

Edwards Lifesciences is seeking a Principal Quality Engineer to drive agility and efficiency in change management processes across the Implant and Delivery System networks. This role will serve as a critical bridge between manufacturing sites and Regulatory Affairs (RA), ensuring timely execution of manufacturing-driven changes while enhancing engineers’ capabilities in technical writing and change documentation. The ideal candidate will have a strong leadership presence, the ability to influence without authority, and a commitment to fostering collaboration across functions. 

How will you make an impact:

• Champion change management excellence by developing and implementing a structured, scalable model for accelerating regulatory-compliant changes
• Act as a key liaison between manufacturing sites and RA, ensuring alignment, transparency, and efficient resolution of escalated issues
• Mentor and coach engineers in technical writing, specifically in crafting effective, clear compliant change documentation and technical summaries to meet regulatory and quality requirements
• Develop standardized tools, templates, and guidance to drive consistency and clarity in change management documentation across manufacturing sites
• Lead and facilitate stakeholder forums to collaboratively assess, prioritize, and execute manufacturing-driven changes, ensuring alignment with regulatory requirements and business needs
• Analyze and monitor change cycle times, identifying roadblocks and opportunities to improve efficiency
• Act as a change agent, fostering a culture of problem-solving, and proactive communication between RA and manufacturing team
• Other duties as assigned

What you'll need (Required):

• Bachelor’s degree in Engineering or Scientific fields with (6) six years of experience in Quality Engineering, Quality Operations, Quality Systems and/or Regulatory Affairs; OR Master’s degree in Engineering or Scientific fields with (5) five years of experience in Quality Engineering, Quality Operations, Quality Systems and/or Regulatory Affairs
• Medical device industry experience
• Strong expertise in technical writing and change documentation proven practices
• Proven leadership ability in driving cross-functional collaboration and drive alignment
• Ability to simplify complex technical and regulatory information for diverse stakeholders
• Strong ability to adapt to shifting priorities and operate effectively in a fast-paced, dynamic environment 
• Skilled in conflict resolution and facilitating collaborative problem-solving 
• Excellent written and verbal communication skills 

What else we look for (Preferred): 

• Regulatory Affairs Professionals Society (RAPS) certification or equivalent
• Knowledge of global regulatory requirements related to medical device 
• Familiarity with Lean, Six Sigma, or other process improvement methodologies

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 $118,000 to $167,000 (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.