Engineer II, Supplier Development Engineering

Edwards Lifesciences•Irvine, CA

3d•Onsite

About The Position

The Engineer II, Supplier Development will be part of the Transcatheter Heart Valve (THV) Supplier Development Engineering team, providing manufacturing engineering leadership to support the design, development, and commercialization of implantable devices and catheter‑based delivery systems for the treatment of cardiovascular disease. This role involves supporting strategic sourcing, developing manufacturing technologies, managing design transfer, and optimizing supplier capabilities to ensure product quality and supply continuity.

Requirements

Bachelor's degree in engineering or scientific field
2 years of experience in new product development, process development, commercialization, and/or operations engineering in a medical device industry
Travel up to 25% domestically and internationally
On-site work required

Nice To Haves

Experience in medical device new product development, including successful design optimization and progression from early development through commercialization.
Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
Hands-on experience with catheter manufacturing processes, such as extrusions, braiding, molding, laser welding, and bonding techniques.
Demonstrated capability to apply sound engineering judgment and technical expertise to solve complex problems; working knowledge of DFM, GD&T, and Six Sigma methodologies.
Experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).
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.

Responsibilities

Support strategic sourcing initiatives, including supplier capability assessments, part qualification strategies, specification reviews, and transition of products into manufacturing.
Develop and mature manufacturing technologies and processes to support new product requirements and scale‑up needs.
Support manufacturing readiness reviews (MRR) and supply chain readiness reviews (SCR), and lead robust design transfer activities into the production environment.
Manage product phase‑in and phase‑out activities, ensuring alignment with design, regulatory, clinical, and manufacturing requirements.
Support supplier validation activities and support milestone builds, NPI commercialization, and seamless integration of new products into manufacturing operations.
Optimize Design for Manufacturability (DFM) by conducting design, drawing, and specification reviews to ensure components meet manufacturing capability and quality expectations.
Assess, develop, and continuously improve supplier part and process capability through data‑driven evaluations and technical collaboration.
Actively engage suppliers in technical discussions to identify and implement product and process improvements that enhance quality, reliability, and cost effectiveness.
Define and execute supplier qualification and validation requirements for OEMs, contract manufacturers (component and device level), and custom material suppliers.
Ensure Tier 1 suppliers effectively manage and qualify Tier 2 suppliers, resolving inter‑company issues to protect product quality and supply continuity.
Align cross‑functional teams (R&D, Quality, Operations, Supply Chain, Regulatory) and suppliers to resolve open issues and meet program timelines.
Partner with suppliers to optimize manufacturing processes, reduce cost, support lean manufacturing initiatives, and eliminate waste.
Perform supplier risk, capacity, and continuity assessments, and drive mitigation plans to ensure successful on time commercialization.
Audit supplier technical capabilities and quality systems to ensure compliance with performance, regulatory, and quality requirements.