Sr. Engineer, R&D

Position Title: Senior Engineer, R&D
Department:  R&D
Reports to: Director, R&D
Status:   Exempt  
Position Summary:

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

Requirements:

  • 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
Other Responsibilities:

  • Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
  • Maintain corporate confidentiality at all times.
 

Living Avinger’s Culture:

As a member of the Avinger team, employees agree to embrace and live out the core values of Avinger, which are:

 

  • Patients first
  • Collaborate
  • Educate
  • Be open-minded

 

The above statements are intended to describe the general nature and level of work being performed; they are not to be construed as an exhaustive list of all responsibilities.

 

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.

 

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