Engineer II, Supplier Development Engineering - Transcatheter Heart Valve

Edwards Lifesciences Corp Irvine , CA 92606

Posted 2 months ago

The 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. Conduct engineering activities from 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, 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.

Essential job functions include:

  • Coordinates tooling / process capability studies as required.

  • Provides 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.

  • 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 for material and outside processing services.

  • Work with supplier to optimize processes.

  • Perform other duties and responsibilities as assigned.

Basic Qualifications:

  • Bachelor's degree in engineering or scientific with 2 years of engineering experience OR Master's degree with a combination of internships, senior projects, or thesis in engineering or scientific field.

Preferred Qualifications:

  • Medical device manufacturing experience in heart valves, stents, catheters, delivery systems and/or interventional access devices is preferred.

  • Understanding of statistical techniques is required.

  • CAD experience using ProE or equivalent is preferred.

  • Effective communication skills.

  • Ability to work well both independently and as a member of a team is essential.

  • Strong analytical, problem solving and technical writing skills.


Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
R&D Engineer I Transcatheter Heart Valve

Edwards Lifesciences Corp

Posted 5 days ago

VIEW JOBS 1/21/2020 12:00:00 AM 2020-04-20T00:00 Join a premier engineering team working at the forefront of new and innovative technologies which directly save lives. Edwards Lifesciences is looking for a high caliber engineer to be a key player in the continued success of our cutting edge transcatheter heart valve program. This is a high visibility and high impact career opportunity working side by side with the leading experts in the field of Transcatheter Aortic Valve Replacement. Edwards Lifesciences is currently seeking an R&D Engineer I to help develop a next generation balloon expandable delivery system for our Transcatheter Heart Valve Business Unit at our corporate headquarters in Irvine, CA. Primary responsibilities include: * Apply Mechanical Engineering knowledge to the design and development of new products * Solve Mechanical Engineering problems at the component through system level * Support early manufacturing process development * Implement design for manufacturability improvements * Conduct testing on devices (both feasibility & Design Verification) * Identify root cause and develop solutions to issues identified during testing * Develop test methods for both feasibility/research & for Design Verification * Create, update, and release quality system documents * Present/communicate findings to influence team/design/management * Design/improve delivery system components and accessories * Work with vendors to improve vendor-supplied components and address issues as they arise * Design fixtures for both manufacturing and device/component testing * Conduct all work in compliance with internal and external policies and procedures, QSR and FDA regulations and ISO standards Required Qualifications: * Bachelor's degree in engineering is required, advanced degree a plus Preferred Qualifications: * Relevant engineering experience via internships, engineering co-ops, or full-time positions is preferred * Must be a highly motivated self-starter who is able to achieve results with minimal direction * Solid problem-solving, organizational, analytical and critical thinking skills * Good communication skills, written and verbal * Experience working in a dynamic team environment * Experience with CAD and/or solid modeling in programs such as CREO or Solidworks a plus * Catheter experience, design, manufacturing, and process development a plus * Knowledge of device Design Control, Quality Systems, documentation a plus #LI-LM2 #MI Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Edwards Lifesciences Corp Irvine CA

Engineer II, Supplier Development Engineering - Transcatheter Heart Valve

Edwards Lifesciences Corp