R-D Engineer II - Exempt

Join Our Team In Santa Rosa, CA

Join our dynamic team in Santa Rosa, CA, where you will have the opportunity to work in a collaborative environment, designing, developing, and launching innovative medical devices. This role is integral to our Interventional Cardiology Therapies, contributing to the advancement of structural heart medical device products and processes.

• Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development.
• Work independently and in a team environment, including lab settings.
• Develop test methods, lead root cause investigations, and create CAD components, assemblies, or drawings.
• Perform protocol-based testing, such as DV, DVal, and lot release.
• Prototype, test, and iterate designs used in the medical field.
• Support the development and integration of new technologies into our product offerings.
• Document research and development processes through lab notebooks, engineering characterization studies, and test reports.
• Engage in early-stage design control activities leading to a first-in-man study, ensuring a robust pilot line that is scalable and transferable to commercial manufacturing.
• Collaborate with Regulatory Affairs to compile US and OUS regulatory submissions and assist with answering questions from regulatory bodies.
• Design and develop new test methods and equipment specific to new products, and train technicians in new processes.
• Create document change orders (CO's) for design, materials, and process documentation.
• Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
• Interact with all departments within the organization and occasionally with external physicians, consultants, and vendors.

• Bachelor's Degree in Engineering (Mechanical, Biomedical, Materials, Chemical).
• 2 years of experience in R&D, Quality, and/or Manufacturing in a regulated industry.
• Prototyping mechanical components and systems.
• Comprehensive understanding and application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
• Ability to provide innovative, thorough, and practical technical solutions to complex problems.
• Successful collaboration as part of a cross-functional team.
• Strong self-motivation and ability to work under general direction, independently determining and developing approaches to solutions.
• Proficiency with computer applications (e.g., Word, Excel, PowerPoint, Minitab).
• Effective communication skills (both written and verbal).

• Master's degree.
• Experience with test method validation.
• Knowledge of design of experiments (DOE) and statistical techniques.
• Experience with structural heart catheter products, processing, and technologies.
• Experience with failure analysis, process improvements, and change management.
• Strong problem-solving capabilities.

Take the next step in your career by joining our team in Santa Rosa, CA, where innovation meets dedication to improving patient outcomes through cutting-edge medical device development.