R-D Engineer II - Exempt

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.

Key Responsibilities

• 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.

Basic Qualifications

• 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).

Nice to Have

• 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.