Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.
This opportunity will reside in the Transcatheter Heart Valve (THV) Supplier Development Engineering
team to provide manufacturing engineering
support in the design
and development of implantable devices and delivery systems to treat cardiovascular disease. This role will be responsible for conducting engineering
activities from initial product
development phase through product
launch, developing manufacturing technologies to meet new product
demands, and managing product
phase in/phase out activities around design
, regulatory and clinical requirements.
Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product
implementation and part transition to manufacturing.
Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
and drawing reviews to ensure that components meet desired capabilities for manufacturing.
Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design
for Test method validation.
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
Develop and manage project milestones in line with development and commercialization needs.
Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
suppliers for their technical capabilities as well as quality criteria
- Bachelor's Degree in Engineering or Scientific field Required
- On-site work required
- Up to 20% domestic/international travel required (as needed)
- Injection molding, extrusion, RF tipping, and/or catheter manufacturing experience preferred.
- Strong analytical, critical thinking, problem solving, and technical writing skills.
- Good computer skills in usage of MS Office Suite.
- Basic understanding of statistical techniques.
- Previous medical device experience preferred.
- Strict attention to detail.
- Ability to manage competing priorities in a fast paced environment.
- Ability to work well both independently and in a team environment.
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 $64,000 to $91,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations
in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government
authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19
vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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