Description
Principal R&D Engineer:Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.
Accountabilities:
- Create product verification plans, test cases, protocols and reports based on product requirements and standards;
- Perform duties as a development team member throughout a product's life cycle by working closely and interfacing with R&D, Marketing, Quality Assurance, Regulatory Affairs, and other groups as necessary;
- Communicate product performance information to the development team, as a result of verification testing activities;
- Initiate, set technical direction, plan, and execute verification testing activities with minimal supervision;
- Possess ability to read, interpret, and communicate product requirements, industry standards, quality system procedures and guidelines;
- Coordinate/oversee verification testing of medical devices with outside specialty labs.
Qualifications:
- Bachelor of Science in an Engineering discipline;
- A minimum of 6+ years work experience in a medical device company
- Strong knowledge of verification methodologies;
- Strong technical skills, including analytical and problem solving skills;
- Experience in a highly regulated development environment, with emphasis on compliance to FDA and European/International standards;
- Ability to mentor and provide technical guidance to others as a result of his/her technical expertise;
- Possess verification testing experience in hardware, software, and system level;
- Strong communication skills both written and oral;
- Ability to self manage multiple high priority assignments;
- Ability to quickly adapt to changing priorities;
- Possess a value added approach to test ( institutional, process and capital value);
- Strong skills in operation and application of measurement instrumentation;
- Owns problems and brings them to full process conclusion;
- Uses test results and data effectively to drive improvement up-stream and down-stream.
To find out more about Real please visit www.realstaffing.com