The Senior Engineer, R&D will work with other members of the product development team to conceive, develop, prototype, test and debug novel catheter systems in accordance with established policies, goals, and objectives; must have the ability to make sound technical decisions, prioritize project deadlines, follow up and complete critical items; required to quickly generate numerous design concepts, narrow down, and select the best option through an appropriate mix of analysis and prototyping; ability to motivate others to reach timelines and deliverables of the projects from concept to commercialization.
Core Job Responsibilities:
- Design prototypes and feasibility models for proof-of-concept testing
- Design and document catheter prototypes through production released products.
- Support efforts to verify and validate new product designs
- Help prepare project plans, specifications, and schedules for new product development
- Prepare and manage Test Protocols, Reports and lab notebooks
- Identify and interact with vendors to obtain engineering materials, processes, and equipment
- Perform routine analysis of test results in relation to design specifications and test objectives
- Assist Engineering Team in maintaining adequate inventory of engineering and prototype materials
- Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to assist in debugging and optimizing system performance
- Assist in the preparation and review of patent applications
- Support manufacture of new and existing products
- Stay current with general engineering knowledge related to catheter design
- Other duties as assigned
- 5+ years’ experience as an engineer in the medical device industry required
- Bachelor’s degree in Mechanical Engineering or Biomedical engineering required; Master’s degree preferred
- Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
- Team player able to work cross functionally
- Must have strong analytical and problem-solving skills, as well as a good background in the product development process
- Extensive knowledge and proven track record of complex Catheter design, Manufacturing process skills and rapid product development.
- Familiar with PC-based office computers including familiarity with Microsoft Word, Excel, PowerPoint, and Outlook.
- Expertise in SolidWorks
- Experience working with ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes
- Previous start-up experience, a plus
- Prior experience with atherectomy catheter and related component design such as high speed drive shaft, handle, and drive mechanism is a plus.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
- Strong creative ability (as demonstrated by a number of patents) as well as IP knowledge is a plus