Edwards Lifesciences · 1 day ago
Sr. Engineer, Supplier Development Engineering
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$106K/yr - $149K/yr
3+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Sr. Engineer, Supplier Development will provide manufacturing engineering support in the design and development of implantable devices and delivery systems, conducting engineering activities from initial product development through product launch.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
The Sr. Engineer, R&D Supplier Development will reside in the Transcatheter Mitral and Tricuspid Therapies (TMTT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease
Conduct engineering activities from the initial product development phase through product launch
Develop manufacturing technologies to meet new product demands
Apply Design for Manufacturability (DFM) concepts, tools and analysis
Conduct reviews to ensure DFM considerations are incorporated into designs
Assess and develop supplier part capability
Work directly with suppliers to address specifications and quality requirements
Lead supplier validation activities (IQ, OQ, PQ), support initial builds and commercialization of new product introduction
Integrate new products into manufacturing
Manage product phase in/phase out activities around design, regulatory and clinical requirements
Support manufacturing readiness reviews and manage design transfers to manufacturing
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
Perform design 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 development and 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
Audit suppliers for their technical capabilities as well as quality criteria
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's Degree or equivalent in Engineering or Scientific field with 4 years' experience including either industry or industry/education OR
Master's Degree or equivalent in Engineering or Scientific field with 3 years' experience including either industry or industry/education
On-site work required
Up to 20% domestic/international travel
Preferred
Experience in the use of statistical tools (SPC, Six Sigma, DMAIC, etc.)
Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices
CAD experience using ProE/Solidworks
Strong analytical, problem solving and technical writing skills
Strong Project management skills
Ability to work well both independently and as a member of a team
Effective verbal/written communication and interpersonal skills including conflict and relationship management
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs to address the diverse individual needs of our employees and their families
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase