Santa Clara, CA

Position Overview

The Sr. Principal R&D Engineer (Technologies Development) will use technical skills in
the development of innovative products to treat peripheral, coronary, and heart valve
diseases. Responsible for advanced research and development of products and
processes, resources, and project management activities associated with
executing the company’s goals and objectives.

Essential Job Functions

• Provide technical leadership for projects including managing engineering
deliverables, team assignments within a project and project timelines.
• Mentor engineers and technicians in best practices and engineering
fundamentals.
• 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 closely with cross functional team leads and program managers during
product development projects.
• Work with the Clinical team 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.
• Lead development teams that manage projects from design and development of
the products.
• Responsible for ensuring 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.
• Develop plans/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.

• 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

• Minimum of 15 years’ experience in engineering preferably in the medical device
industry.
• Bachelor’s Degree in Mechanical, Biomedical Engineering required. Master’s or
PhD preferred.
• Experience developing single-use medical devices.
• Knowledge of single-use peripheral and coronary device design, material
selection, and testing.
• Experience in early-stage catheter based cardiovascular device development.
• Experience with catheters employing electrically based functions is a strong plus.
• Strong understanding of engineering materials, component selection, and design
for reliability and manufacturability.
• Strong understanding of engineering statistics including capability, tolerance
intervals, Gage R&R, and Design of Experiments (DOEs).
• Previous experience managing and/or leading cross functional teams is preferred.
• Previous experience as a technical lead on a product development project.
• Successful track record developing products under design control through
product launch.
• 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.
• Employee may be required to lift objects up to 25lbs.