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 13

Edwards Lifesciences · Medical Devices

Sr. Quality Engineer, NPD - IHFM

  • Irvine, CA
  • On-site
  • Full-time
  • Senior & Principal
Save
EmploymentFull-time
Deadline

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 provided
How this compares
  • Competitive 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, 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 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

$108,000 to $153,000 a year

Senior & Principal roles in California68 roles publishing pay

Middle half $123,000 to $159,750, median $135,750

Senior & Principal roles in the US226 roles publishing pay

Middle half $105,625 to $140,875, median $124,000
Annual base pay
Annual base payLowMedianHigh
This role$108,000—$153,000
California$123,000$135,750$159,750
All US$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.

  1. One step back

    Associate & Specialist

    Often: Quality Engineer · Intern

    $84K median162 open
  2. This role

    Senior & Principal

    Often: Quality Engineer · Senior Quality Engineer

    $124K median290 open
  3. Next step

    Manager

    Often: QA Supervisor · Supplier Quality Manager

    $150K median100 open
  4. Later

    Director

    Often: Associate Director · Associate Director, Quality Assurance

    $210K median78 open
  5. Later

    VP & Executive

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

    $293K median12 open

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.

GMP and compliance: 2 linesLab testing and methods: 2 linesDocumentation and SOPs: 2 linesValidation and qualification: 2 linesQuality systems and risk: 2 linesCollaboration and leadership: 3 linesGMPLab testingDocumentationValidationQuality systemsTeamwork
  • Collaboration and leadership3
  • GMP and compliance2
  • Lab testing and methods2
  • Documentation and SOPs2
  • Validation and qualification2
  • Quality systems and risk2

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%
See all 23 Edwards Lifesciences roles

More roles at Edwards Lifesciences

All 23 Edwards Lifesciences roles

Similar Quality Assurance roles elsewhere

Sr. Quality Engineer, NPD - IHFM at Edwards Lifesciences

Applications close November 12. $108K–$153K a year, employer provided.

Job alerts