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Job Details
Engineer I, NPD
Type
Full time
Category
Engineering
Location
USA - California – Irvine
Job reference
Req-48179
Posted for
3 days ago
Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.
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.
How you'll make an impact:
Support design control activities for manufacturing product and process development
Develop manufacturing documentation (drawings, SOPs, routers, pFMEA) across various release stages and create training materials to enable seamless knowledge transfer to production
Support process definition and development of process controls
Provide operations input into specifications (DFx, tolerancing, material selection, automation), supporting stability metrics and risk mitigation through SCRR and MRR
Collaborate on build strategy, prioritization, and technical support for QST, pre-DV, and DV; partner with Pilot on root cause investigations prior to commercialization
Support development and execution of experiments and test protocols to characterize and refine processes; assist with qualifications and validations (IQ, OQ, software)
Support manufacturing equipment engineering and tooling design for program-specific needs
Assist in analysis of manufacturing and compliance issues (CAPA, non-conformances, audit observations) and support process transfer activities
Identify opportunities to redesign equipment, tools, and fixtures to improve manufacturing processes
Drive continuous improvement using engineering methods (LEAN, basic statistics)
Perform other duties as assigned by leadership
What you’ll need (Required):
Bachelor's Degree in Engineering or Scientific field
What else we look for (Preferred)
Demonstrate strong proficiency in MS Office Suite (including MS Project); CAD experience preferred, if applicable
Apply clear written and verbal communication skills with strong interpersonal effectiveness
Demonstrate a basic understanding of statistical techniques
Show experience working with lab or industrial equipment, if applicable
Apply foundational engineering principles, theories, and concepts
Solve problems effectively using strong organizational, analytical, and critical thinking skills
Demonstrate understanding of processes and equipment relevant to assigned work
Adhere to Edwards Environmental Health & Safety and Quality guidelines, including clean room medical device manufacturing standards
Maintain strict attention to detail
Interact professionally across all organizational levels
Manage competing priorities effectively in a fast-paced environment
Collaborate effectively in a team environment, including working with supervisors, cross-functional teams, and external vendors
Build and maintain stable internal working relationships
Adhere to all company rules and requirements (e.g., pandemic protocols, 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 $69,000 to $98,000 (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.
Job reference
Req-48179
Type
Full time
Category
Engineering
Location
USA - California – Irvine
Posted for
3 days ago
About Edwards Lifesciences
Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.
What we offer
Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.
Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.