Senior R&D Engineer – Sustaining Engineering

Location: Carlsbad, CA

Job Type: Year Long Contract with opportunity to extend

Pay Rate: $60.00 - $68.00/hour or up to $138,000 a year

Work Schedule: Full Onsite

Work Authorization: Applicants must be authorized to work in the U.S. without current or future visa sponsorship. Sponsorship is not available for this position.

The client is seeking a highly motivated R&D Engineer to join the Intravascular Lithotripsy (IVL) Sustaining R&D Team in Carlsbad, CA.

The IVL Sustaining Engineering team provides design ownership and technical support for commercialized medical devices, ensuring patient safety, product quality, regulatory compliance, manufacturing continuity, and long‑term product performance. This role will support sustaining engineering activities for Class II and III catheter‑based medical devices throughout the product lifecycle.

The R&D Engineer will be responsible for supporting commercialized IVL products through design changes, supplier and material modifications, manufacturing support, quality investigations, shelf‑life and labeling updates, and technical assessments. The position plays a critical role in maintaining product performance, regulatory compliance, patient safety, and supply continuity.

Working with limited supervision, the engineer will analyze and interpret design, manufacturing, quality, complaint, testing, and research data to ensure design intent is maintained after product launch. This individual will serve as a key technical contributor on cross‑functional sustaining projects while providing product and clinical‑use expertise.

• Execute design change activities and ensure proposed changes are thoroughly evaluated through established design control and change management processes.
• Develop technical justifications and supporting data to verify that product design intent is maintained following modifications.
• Partner with Quality, Manufacturing, Regulatory Affairs, Clinical, Marketing, and Project Management teams to support product lifecycle activities and project success.
• Collaborate with manufacturing teams to identify and implement design improvements that reduce costs and improve efficiency.
• Evaluate field feedback, complaint trends, and product performance data to identify opportunities for product enhancements.
• Provide technical expertise related to device performance, anatomy interaction, and clinical use.
• Interface with suppliers, physicians, and external partners as required to support project objectives.
• Lead and support quality investigations, root cause analyses, and corrective actions related to product performance and reliability.
• Troubleshoot product, process, material, and design‑related issues.
• Plan and manage individual project activities to meet established timelines and deliverables.
• Analyze test results, draw technical conclusions, and prepare reports and documentation to communicate findings.
• Participate in cross‑functional teams to resolve complex technical issues and drive continuous improvement initiatives.
• Provide technical guidance and effectively communicate within multidisciplinary and global teams.
• Maintain a strong commitment to patient safety, product quality, and regulatory compliance.

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Engineering, Chemical Engineering, or a related engineering discipline.
• Minimum of 5+ years of engineering experience within a regulated medical device environment.
• Experience supporting commercialized medical devices through sustaining engineering, product lifecycle management, or design change activities.
• Strong understanding of:
• Design Controls
• Change Control Processes
• Technical Documentation
• Experience working in cross‑functional teams and managing multiple projects simultaneously.
• Strong technical writing, analytical, problem‑solving, and communication skills.

• Experience with catheter‑based devices, intravascular products, or other Class II/III sterile single‑use medical devices.
• Knowledge of polymeric materials, extrusions, bonding technologies, adhesives, coatings, laser welding, sterilization, packaging, and high‑volume disposable device manufacturing.
• Experience supporting manufacturing operations and product cost reduction initiatives.
• Demonstrated success leading technical investigations and sustaining engineering projects in a fast‑paced medical device environment.