Principal R&D RF Engineer
The Principal R&D Engineer will be responsible for product design and development of RF ablation catheters for renal nerve ablation systems. Responsibilities include completion of bench testing and pre-clinical animal studies to define key design and ablation algorithm parameters and translation of performance requirements into product specifications.
Successfully complete complex engineering work in one or more of the following independently and as part of a team:
technology development, product design and development, preparation of product specifications, research investigation (animal and clinical studies), and report preparation.
Summarize, analyze, and draw conclusions from complex test results using valid statistical techniques.
Design and prepare reports to effectively communicate results clearly and completely to technical community.
Interface with Physicians and/or Catheterization Lab personnel to obtain feedback on concepts and performance of new devices.
Translate customer needs into product requirements and design specifications.
Consistently generate innovative and unique solutions to market needs and submit invention disclosures.
Work is expected to result in the development of new or refined products or processes.
Drive design verification and validation activities for catheter and system specifications.
May train and/or provide work direction to technicians and entry-level engineers.
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements
The above statements are intended to describe the general nature and level of work being performed
by people assigned to this classification.They are not intended to be construed as an exhaustive list
of all responsibilities, duties and skills required of personnel so classified.
Please contact your local EH&S department for more information on physical requirements.
BS in Mechanical, Chemical, Biomedical or a related Engineering field required; 8+ years’ experience (7+ years with MS, 4+ years with Ph.D.).
Work closely with other members of the project team (marketing, process development, quality, and regulatory) to ensure a robust, manufacturable design that will meet all performance, quality and regulatory requirements.
Strong communication, collaboration and critical-thinking skills, as well as solid understanding of risk management are the critical skill-sets required of this position.
Required Specialized Skills:
RF ablation catheter design and test experience.
Competent in the application of Design of Experiments methodology (Design-Expert) & statistical analysis software (Minitab preferred)
- Experience with qualifying medical devices to electrical standards (i.e. 60601)
Prepare design /engineering documentation aspects in support of FDA submissions
- Experience with design controls, FDA regulation, GMP practices, and QSR requirements.
Expected Travel Time: None
This company may offer relocation assistance.
Monster - 19 months ago
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...