Edwards Lifesciences · 1 day ago
Manager, Supplier Development Engineering
USA - California – Irvine
Full-time
Onsite
Mid, Senior Level
$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 Manager, Supplier Development Engineering will provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease, overseeing supplier validation activities and managing product transitions to production.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Position 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
Manage and/or lead a small team within assigned function. Develop team members to increase business acumen and functional skills
Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables
Identify opportunities and lead the implementation of changes to drive improvements
Work on complex issues where analysis of issues requires in-depth knowledge
Create/update complex engineering documents including requirement specs, and risk documents with robust knowledge on design control requirements
Oversee engineering tasks; provide technical guidance and feedback to technicians/engineers; Guide lower level employees on more complex procedures
Qualification
Required
Bachelor's Degree in a related field and experience in engineering
Preferred
Master's Degree in a related field and 5-6 years of Engineering experience
Demonstrated track record in management of technical and/or engineering disciplines
Experience working in a regulated industry
Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
Proven successful project management skills
Proven expertise in both Microsoft Office Suite and related systems
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Extensive understanding of engineering procedures while defining team operating standards
Extensive understanding of related aspects of engineering processes and/or systems
Basic financial acumen as it relates to engineering (e.g., material and capital expenditures and product costing)
Demonstrated skill set to manage small team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to influence cross-functional partners
Ability to integrate metrics into the projects and operations
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Primarily interacts with internal subordinates and other supervisors
Typically interacts with external suppliers, vendors and/or customers
Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
Dedicated to quality client service and pro-active and responsive to client needs
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
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
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