Edwards Lifesciences · 6 hours ago
Principal Engineer, Supplier Development Engineering
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$118K/yr - $167K/yr
5+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Principal Engineer, Supplier Development position involves providing manufacturing engineering support in the design and development of implantable devices and delivery systems, conducting engineering activities from product development through launch, and managing supplier relationships to ensure quality and efficiency.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
The Principal Engineer, Supplier Development 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
Conduct engineering activities from the initial product development phase through product launch
Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing
Develop manufacturing technologies to meet new product demands
Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment
Manage product phase in/phase out activities around design, regulatory and clinical requirements
Lead supplier validation activities, support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing
Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability
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
Lead recurring technical meetings with critical outsourced component/ assembly suppliers
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 in Engineering or Scientific field, minimum of 6 years of experience OR
Master's Degree in Engineering or Scientific field, minimum of 5 years of experience OR
Ph.D. or equivalent in Engineering or Scientific field, minimum of 2 years of experience
On-site work required
Up to 20% domestic/international travel
Preferred
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.)
Experience in catheter assembly and related sub-assembly components manufacturing technologies in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices
Proven expertise in usage of MS Office Suite
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills
Ability to translate technical information to all levels of the organizations
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
Advanced problem-solving, organizational, analytical and critical thinking skills
Extensive understanding of processes and equipment used in assigned work
Strong leadership skills and ability to influence change
Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
Strict attention to detail
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 frequent inter-organizational and outside customer contacts
Represents organization in providing solutions to difficult technical issues associated with specific projects
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
Benefits
Competitive salaries
Performance-based incentives
Wide variety of benefits programs
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
BioWorld Financial Watch
2026-01-15
Orange County Business Journal
2026-01-14
2026-01-13
Company data provided by crunchbase