Regulatory Jobs
Hero Gradient Background
Two Edwards colleagues in cleanroom gowns and masks making heart shapes with their gloved hands
Edwards Lifesciences logo

New · posted Oct 20

Edwards Lifesciences · Medical Devices

Principal Engineer, NPD-Quality

  • Irvine, CA
  • On-site
  • Full-time
  • Senior & Principal
Save
Pay$121K–$171Ka year · employer provided
EmploymentFull-time
LocationIrvine, CAOn-site
LevelSenior & Principal
FunctionQuality AssuranceQuality
Deadline

Closes Oct 23, 2026 · 4 days left

The role

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This Principal Quality Engineer, NPD will be part of Edwards Lifesciences growing Transcatheter Heart Valve (THV) business in Irvine, CA. 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 with a minimum of six (6) years related experience required; OR a Master’s Degree in Engineering or Scientific field with a minimum of five (5) years related experience; OR a PhD in Engineering or Scientific field with a minimum of two (2) year related experience.

· Knowledge of and experience with design control, risk management/usability engineering within medical device industry or other regulated industries is required

· Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations (FDA 21 CFR 820, ISO 13485, ISO 14971, ISO 62366; and other applicable regulatory requirements)

· Must be able to work in a team environment, including inter-departmental teams and key stakeholders representing the organization on projects

What else we look for (Preferred)nice to have

· Current or prior experience within Medical Device industry

· Quality Engineering experience in New Product Development

· 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).

· ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus

· Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills

· Abiliy 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

· 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

· Basic understanding of statistical techniques

· Strong problem-solving, organizational, analytical and critical thinking skills

· Experience in people leadership including direct line reporting responsibilities

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.

Skills named in this posting

What you'll do

How you will make an impact

· Providing 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 failure investigations for product failures in design testing and clinical use

· 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.

· Managing/overseeing the work of an assigned team of direct reports within own function.

· Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.

· 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 10% domestically and internationally

Pay and benefits

$121,000 – $171,000 a year

Employer provided
How this compares

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 $121,000 to $171,000 (highly experienced).

  • Performance-based incentives

  • Competitive salary

  • 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, CA
Equal 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 20, 2026

Salary intelligence

How the pay compares

This role's midpoint is 21% above the US median for Quality Assurance roles at this level.

This roleEmployer provided

$121,000 to $171,000 a year

Senior & Principal roles in California89 roles publishing pay

Middle half $116,000 to $158,500, median $135,000

Senior & Principal roles in the US302 roles publishing pay

Middle half $102,625 to $137,500, median $120,250
Annual base pay
Annual base payLowMedianHigh
This role$121,000—$171,000
California$116,000$135,000$158,500
All US$102,625$120,250$137,500

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 20, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Quality Assurance

The general path across 895 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Quality Technician

    $81K median243 open

  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $120K median381 open

  3. Next step

    Manager

    Often: Manager, Quality Assurance · Quality Manager

    $155K median138 open

  4. Later

    Director

    Often: Director, Quality · Associate Director, Quality Assurance

    $209K median118 open

  5. Later

    VP & Executive

    Often: AVP · Executive Director Quality, Cell & Gene Therapy

    $302K median15 open

Career resources on Quality Assurance

Skills DNA

What this role leans on

How many of the posting's 35 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

GMP and compliance: 5 linesLab testing and methods: 5 linesDocumentation and SOPs: 3 linesInvestigations and CAPA: 1 lineValidation and qualification: 3 linesQuality systems and risk: 6 linesCollaboration and leadership: 14 linesGMPLab testingDocumentationInvestigationsValidationQuality systemsTeamwork
  • Collaboration and leadership14
  • Quality systems and risk6
  • GMP and compliance5
  • Lab testing and methods5
  • Documentation and SOPs3
  • Validation and qualification3
  • Investigations and CAPA1

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.

From Regulatory News

Manufacturing and quality coverage for this profession

Company hiring pulse

Edwards Lifesciences on Regulatory Jobs

28
Open roles
27
Distinct roles
4
Locations

By discipline

  • Quality19 68%
  • Regulatory8 29%
  • Compliance & Safety1 4%

By level

  • Senior & Principal16 57%
  • Associate & Specialist8 29%
  • Director2 7%
See all 28 Edwards Lifesciences roles

More roles at Edwards Lifesciences

All 28 Edwards Lifesciences roles

Similar Quality Assurance roles elsewhere

Principal Engineer, NPD-Quality at Edwards Lifesciences

Applications close October 23. $121K–$171K a year, employer provided.

Job alerts