New Product Development Engineer II, TMTT

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company driven by a passion to improve patient lives. With millions of patients served in over 100 countries each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Senior Engineer NPDposition is a unique career opportunity that could be your next step towards an exciting future.

Join our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit as an NPD Engineer advancing an innovative portfolio of technologies for patients with complex heart valve this role you will contribute across the product lifecycle from Early Human Use through commercialization by developing and optimizing manufacturing processes that address critical unmet clinical needs. You will collaborate closely with R&D Pilot and commercial manufacturing teams playing a key role in delivering lifechanging therapies that help patients live longer healthier lives.

How youll make an impact:

• Drive early-stage New Product Introduction (NPI)by developing and implementing scalable manufacturing processes and technologies that enable high-capacity sustainable product lines within the TMTT portfolio.

• Support new product developmentby contributing to the design and development of implantable devices and delivery systems for cardiovascular therapies from early concept through product launch.

• Execute engineering activities across the full development lifecycle including design control support for manufacturing products and processes.

• Own nonconformance and MRB activitiesto support initial and early-phase manufacturing builds.

• Develop and execute operations strategiesto successfully integrate new products into manufacturing including product phasein and phaseout activities aligned to design regulatory and clinical requirements.

• Lead manufacturing readiness and design transfer activities including manufacturing readiness reviews (MRRs) and successful transfer of designs to production.

• Influence product and process specificationsfrom an operations perspective applying DFx principles tolerancing material selection and automation to establish stability metrics assess risk and drive mitigation via SCRR and MRR forums.

• Develop and release manufacturing documentation including drawings SOPs routers pFMEAs and midcomplexity training materials and work instructions to ensure effective knowledge transfer to production.

• Improve manufacturing processesthrough application of LEAN principles and basic statistical methods to drive continuous improvement reduce nonvalueadded work and positively impact cost standards and operational efficiency.

• Support drive and execute process qualifications and validations including IQ OQ and PQ activities for manufacturing processes.

• Lead and support build strategiesfor QST preDV and DV phases by prioritizing activities and providing handson technical expertise.

• Partner with Pilot manufacturing teamsto conduct root cause investigations for manufacturing issues prior to commercialization.

• Identify and implement equipment tooling and fixture improvementsto enhance manufacturing capability efficiency and robustness.

• Apply Design for Manufacturability (DFM) principlesby conducting design reviews and ensuring manufacturability considerations are embedded early in product development.

• Contribute flexibly to additional responsibilities and initiativesas business and project needs evolve.

What youll need (Required):

• Bachelors Degree in Engineering or Scientific field with 2 years related experience including either industry or industry/education OR

• Masters Degree in Engineering or Scientific field or equivalent with related internship senior projects or thesis in industry/education

What else we look for (Preferred):

• Demonstrated analytical and problemsolving skills including the ability to assess complex technical challenges and develop effective datadriven solutions in a fastpaced development environment.

• Strong written and verbal communication skills with proven ability to generate clear concise and accurate technical documentation.

• Ability to work effectively in a highly collaborative crossfunctional team environment including frequent interaction with R&D manufacturing quality suppliers and external stakeholders.

• Proven interpersonal consultative and relationshipmanagement skills including the ability to influence negotiate and align stakeholders without direct authority.

• High attention to detail and strong organizational skills to ensure accuracy compliance and execution excellence throughout the development lifecycle.

• Ability to work independently while managing competing priorities and delivering results with minimal oversight.

• Experience coordinating and managing vendors and project stakeholders in support of technical and program objectives.

• Proficiency with Microsoft Office tools including Word Excel PowerPoint and MS Project; CAD experience preferred where applicable.

This position may include travel of up to 10% for product transfer initiatives.