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Associate R-D Engineer
Ref No.: 18-46513
Location: Santa Rosa, California
Start Date / End Date: 09/24/2018 to 01/31/2020
Company: Artech Information Systems
Job Title:  Associate R-D Engineer
Location: Santa Rosa, CA      
Duration: 15+ months
Job Id: 18-46513
The main purpose of this job is to support development of current and next generation drug-coated balloon (DCB) projects to treat peripheral vascular disease. These combination products integrate biotechnology, polymer science, and pharmaceutical molecules onto balloon platforms. The employee will be a member of multiple projects through different stages of the product development cycle, bringing products to commercialization.
  • Assist in the development of new combination products and components.
  • Support the development and integration of new technologies into the CardioVascular product offering.
  • Provide assistance to interdepartmental team for new product introduction.
  • Take an active role in early stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scaleable and transferable to commercial manufacturing is achievable.
  • Document research and development process through lab notebooks, engineering characterization studies, and test reports.
  • Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
  • Design and develop new test methods and equipment specific to new products. 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.
  • Perform competitive product analyses.
  • Work with patent counsel to file and evaluate intellectual property.
  • Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
  • Minimum travel requirement of 10%.
Education Required
Bachelor’s Degree in Engineering (Chemical, Materials, Mechanical or Biomedical) or Chemistry
Years of Experience
2+ years
Specialized Knowledge or Skills Required
  • Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.
  • Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.
  • Able to provide imaginative, thorough and practical technical solutions to a wide range of difficult problems, consistent with company’s objectives.
  • Successful collaboration as part of a cross-functional team.
  • Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.
  • Proficient with computer applications (i.e. Word, Excel, PowerPoint, Minitab, etc.).
  • Ability to communicate well (both written and verbal).
  • Master’s degree.
  • 2+ years working in R&D, Quality and/r Manufacturing on combination medical devices.
  • Experience with test method validation.
  • Knowledge of design of experiments (DOE) and statistical techniques.
  • Proficient with SolidWorks.
Rajiv Maruthi