R&D Engineer III

Description:

About the role:
Client* is seeking a highly motivated R&D Engineer to join the Carlsbad Intravascular Lithotripsy (IVL) Sustaining R&D team.

The IVL Sustaining Engineering R&D group provides design ownership and technical support for commercialized IVL products, ensuring patient safety, product quality, regulatory compliance, manufacturing continuity, and lifecycle value.

Job Purpose

Responsible for sustaining commercial IVL devices throughout the product lifecycle, including design changes, supplier and material changes, manufacturing support, quality investigations, shelf-life and labeling updates, and technical assessments needed to maintain product performance, regulatory compliance, patient safety, and supply continuity.

With limited supervision, the role involves compiling, analyzing, and reporting design, manufacturing, quality, complaint, testing, and research data to ensure design intent is maintained after launch. The candidate will serve as a key technical resource for cross-functional sustaining projects and provide product and clinical-use expertise.

Key Responsibilities
•Use of the design change process to ensure proposed changes are systematically and thoroughly analyzed before beginning the change process. Whenever product changes are proposed, justification is written, or data is collected to verify that the design intent is still met.
•Works cross-functionally with project management, quality, manufacturing, regulatory, clinical,l and marketing to ensure project success.
•Work collaboratively with manufacturing to reduce product costs through design improvements.
•Works with other functions to understand feedback from the market, providing design knowledge input to understand device performance and anatomy interaction, look for opportunities for device improvement, and interact with physicians as necessary to optimize outcomes.
•Interfaces with vendors and physicians where projects require.
•Maintain product performance through Quality Investigations and ensure rigorous support for design changes.
•Works independently to plan and schedule own activities necessary to meet timelines.
•Performs troubleshooting on products/process problems as related to design, material, or process.
•Summarizes, analyzes,s and draws conclusions from test results, prepares standard reports/documentation to communicate results to the technical community.
•Must be able to provide technical guidance within a team and be an effective communicator within a multidisciplinary and international organization.
•Leads or participates in a cross-functional team to perform troubleshooting on products/process problems as related to design, material, or process.
•Demonstrates a primary commitment to patient safety and product quality.

Qualifications
•Bachelor''s degree in Mechanical Engineering, Biomedical Engineering, Materials Science/Engineering, Polymer Engineering, Chemical Engineering, or a related technical discipline with a minimum of 7 years of relevant experience; or Master''s degree with a minimum of 5 years of relevant experience; or Ph.D. with a minimum of 3 years of relevant experience.
•Minimum of 5 years of experience in the medical device industry preferred, with direct experience in catheter-based disposables, intravascular devices, or other Class II/III sterile single-use devices strongly preferred.
•Demonstrated experience with design controls, change control, risk management, design verification/validation, test method development, root cause analysis, and technical documentation in an FDA-regulated medical device environment.
•Strong technical knowledge of catheter design, polymeric materials, extrusions, bonding technologies, adhesives, coatings, laser welding, sterilization, packaging, and/or high-volume disposable device manufacturing preferred.
•Proven ability to lead technical problem solving in a fast-paced, cross-functional environment, manage multiple sustaining projects simultaneously, communicate clearly with technical and non-technical stakeholders, and maintain a primary commitment to patient safety and product quality.