Staff R&D FEA Engineer - Shockwave

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Staff R&D FEA Engineer – Shockwave to join our team located in Santa Clara, CA.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Staff R&D FEA Modeling Engineer will specialize in finite element analysis (FEA) and will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff R&D FEA Modeling Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

Essential Job Functions

• Design and develop product(s) in compliance with the company’s Design Control requirements and applicable regulatory requirements.

• Develop proof of concept designs and bench models to test these concepts in a simulated environment.

• Perform FEA simulation for projects in the coronary, peripheral vascular, and structural heart space.

• Develop simulations to optimize design for cardiovascular products

• Oversee material testing to provide input to FEA

• Develop new products based on defined user needs.

• Develop and maintain technical documentation such as drawings for components and assemblies for products

• Solve challenging and complex technical problems using computational modeling methods during the new product development process.

• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.

• Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs.

• Identify suppliers and maintain relationships to ensure the delivery of superior components and services.

• Enhance the intellectual property position of the company via invention disclosures and patent applications.

• Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team.

• Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.

• Ensure proper documentation consistent with the company’s quality system.

• Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.

• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.

• Responsible for component and assembly documentation for new products being developed.

• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.

• Other duties as assigned.

Requirements

• Master’s degree in mechanical or biomedical engineering with 6 years’ experience in engineering OR a PhD and 4 years’ experience in engineering.

• 3 years’ engineering experience in the medical device industry

• Knowledge of disposable peripheral and coronary device design, material selection, and testing

• Strong understan