Senior R&D Engineer

Endovascular Engineering•Menlo Park, CA

About The Position

The Senior R&D Engineer designs and develops new and improved products and procedures addressing vascular diseases and conditions using minimally invasive techniques. The role focuses on catheter-based disposable medical devices and supports product development from initial concept through commercialization and launch. The engineer works cross-functionally to evaluate designs, complete design control activities, prepare technical and regulatory documentation, and support the company’s Quality System.

Requirements

At least 5 years of experience leading development of disposable medical device products.
Experience with design and process development of medical device catheters.
Experience with FDA and ISO standards for medical device design controls and manufacturing.
Bachelor of Science in Engineering, Mechanical or Biomedical.
Working knowledge of common catheter materials and construction methods.
A successful track record of developing disposable medical products from conceptualization through product launch.
Self-motivated, with the ability to work independently and with minimal supervision.

Responsibilities

Design, prototype, and develop novel catheter-based products to improve performance and ease of use in clinical procedures.
Work with a cross-functional team to develop and evaluate product designs through verification and validation testing.
Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions.
Provide periodic project status updates.
Contribute to the company’s intellectual property through invention disclosures, brainstorming sessions, and prototypes demonstrating reduction to practice.
Interact with physicians regarding product development, testing, and product demonstrations.
Train team members on product assembly and troubleshoot assembly process issues.
Maintain Design Control activities for new product development from initial concept through commercialization, including developing product specifications, performing robust design evaluation, creating risk analyses, meeting design review goals, and setting and executing design verification and validation strategies.
Collaborate with R&D, Marketing, Operations, Quality, Clinical, and Regulatory functions to support project success.
Support development and upkeep of the Company’s Quality System in conjunction with the Quality Department.