Engineer Medical Device R&D – FILLED
The Wellington Group has been engaged to find an experienced Engineer Medical Device R&D with RF ablation catheter design and testing experience for a global leader medical device. Excellent opportunity to make an immediate impact with a great company, Who Do You Know?
The Engineer Medical Device R&D 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: 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
- Consistently generate innovative and unique solutions to market needs and submit invention disclosures
- Drive design verification and validation activities for catheter and system specifications
- Build Quality into all aspects of work by maintaining compliance
The qualified candidate will have:
- 4+ years experience in design and development of medical devices, hands on experience with RF ablation catheter is required
- BS, MS or PhD in Mechanical, Chemical, Biomedical or a related Engineering field
- Strong communication, collaboration and critical-thinking skills
- Solid understanding of risk management
- Experience with qualifying medical devices to electrical standards
- Competent in the application of Design of Experiments methodology (Design-Expert) & statistical analysis software (Minitab preferred)
- Experience with design controls, FDA regulation, GMP practices, and QSR requirements
- Prepare design /engineering documentation aspects in support of FDA submissions
Industry: RF, Medical Device, catheter, ablation, design, engineering, R&D
Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)