Santa Clara, CA

Position Overview

The Principal R&D Engineer will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization.

Essential Job Functions

• Provide technical leadership for projects including managing technology development teams.
• Responsible for managing 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.
• Analyzes, evaluates, sources, and coordinates 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.
• Responsible for ensuring proper documentation consistent with company’s quality system.
• Responsible for knowing and planning 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.
• 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

• 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.
• Effective communication skills with all levels of management and organizations.
• Operate independently and adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Previous experience managing cross functional teams is preferred.
• Employee may be required to lift objects up to 25lbs.