Principal R&D Engineer - Shockwave Medical

About the role

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

Responsibilities

• Provide technical leadership for projects including managing technology development teams
• Manage technology and other relevant resources
• Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements
• Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs
• Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
• Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization
• Ensure proper documentation consistent with company’s quality system
• Know and plan activities consistent the company’s quality policy and quality objectives
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing
• Perform process-related design tasks to support pilot manufacturing as necessary
• 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
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations

Requirements

• Bachelor’s Degree in Mechanical or Biomedical Engineering and 10 years’ experience in engineering OR a Master’s Degree and 8 years’ experience in engineering
• Engineering experience in the medical device industry
• Experience developing disposable medical devices
• Knowledge of disposable peripheral and coronary device design, material selection, and testing
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
• Experience in early-stage catheter based cardiovascular devices development is a strong plus
• Strong hands-on experience with CAD software like Solidworks
• Effective communication skills with all levels of management and organizations
• Ability to work in a fast-paced environment, managing multiple priorities
• Previous experience managing cross functional teams is preferred

Preferred Skills

• Bioinformatics
• Biological Engineering
• Biostatistics
• Clinical Trials Operations
• Coaching
• Communication
• Critical Thinking
• Global Market
• Healthcare Trends
• Medical Affairs
• Organizing
• Product Development
• Project Reporting
• Research and Development
• Researching
• Resource Planning
• SAP Product Lifecycle Management