Sr R&D Engineer

Overview

• Independently conducts development work as part of a major research and/or development project.
• Receives minimal technical direction/review on broad scope or complex projects.
• Viewed as an expert in one or more in-house technologies.
• Focused on next generation access and delivery catheter. 510k submission by next year.
• Operating in a 510k submission lens.

• Work with a small team of new product design engineers focused on the design of a new large bore delivery catheter.
• Works independently to develop key deliverables as part of a 510k regulatory submission. Deliverables include, but not limited to: CAD design, detailed print packages, specification generation and rationale, specification mapping to essential design outputs, DFMEAs, tolerance analysis, device material assessment(s), and bill of materials.
• Provides guidance to product and technology teams.
• Assesses the feasibility and soundness of alternative engineering processes, products, or equipment.
• Coordinates, manages, and documents project goals and progress and recommends appropriate revisions.
• Develop and coach others on engineering documentation.
• Demonstrates PDP/TPD system knowledge through coaching and delivery of high quality, high impact deliverables.

• Minimum of a bachelor's degree in mechanical or biomedical engineering (or other related technical discipline).
• Experience working with medical devices (catheter or delivery systems is highly preferred).
• 4+ years of experience in design assurance, new product development or related medical device / regulated industry experience.
• Experienced in design controls, print packages, tolerance analysis, GD&T.
• Windchill and Solid Works experience (ability to create 2D drawings).
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
• Experienced problem solver, capable of facilitating the problem-solving process.
• Adaptable and effective collaborator in a team environment or in self-directed work.
• Experience with design changes, complaint reduction, and corrective action.

• Experience working with catheter or delivery systems.
• Quality Integration experience.
• 510k regulatory experience.