

New · posted Oct 13
Edwards Lifesciences · Medical Devices
Sr. Quality Engineer, NPD - IHFM
- Irvine, CA
- On-site
- Full-time
- Senior & Principal
Closes Nov 12, 2026 · 30 days left
The role
Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.
What you need
What you'll need (Required)
• Bachelor's Degree in Engineering or Scientific field, 4 years’ experience including either industry or industry/education or
• Master's Degree or equivalent in Engineering or Scientific field, 3 years’ experience including either industry or industry/education or
• Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education
What else we look for (Preferred)nice to have
• Current or prior experience within Medical Device industry
• Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
• New Product Development experience from initial concept to commercialization (Class III preferred).
• Experience with Risk Management and Design Control
• Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations
• Proven expertise in usage of MS Office Suite including MS Project
• Advanced understanding of statistical techniques
• Strong problem-solving, organizational, analytical and critical thinking skills
• Quality Engineering experience in New Product Development is preferred
• Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects
• ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus
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 (CA), the base pay range for this position is $108,000 to $153,000 (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.
What you'll do
How you will make an impact
• Provide technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
• Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
• Lead development and drive updates to risk management files for new products
• Lead test method development and validation activities for new designs
• Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing
• Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering
• Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
• Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
• Performs other incidental duties as assigned by management
• Ability to travel up to 20% domestically and internationally
Pay and benefits
$108,000 – $153,000 a year
Employer providedCompetitive salaries
Performance-based incentives
Wide variety of benefits programs for employees and families
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · October 13, 2026
Salary intelligence
How the pay compares
This role's midpoint is 5% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in California68 roles publishing pay
Senior & Principal roles in the US226 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $108,000 | — | $153,000 |
| California (middle half) | $123,000 | $135,750 | $159,750 |
| All US (middle half) | $105,625 | $124,000 | $140,875 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 13, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 642 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 5 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership3
- GMP and compliance2
- Lab testing and methods2
- Documentation and SOPs2
- Validation and qualification2
- Quality systems and risk2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 23
- Open roles
- 22
- Distinct roles
- 3
- Locations
By discipline
- Quality16 70%
- Regulatory6 26%
- Compliance & Safety1 4%
By level
- Senior & Principal14 61%
- Associate & Specialist5 22%
- Director2 9%
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Sr. Quality Engineer, NPD - IHFM at Edwards Lifesciences
Applications close November 12. $108K–$153K a year, employer provided.

