R&D Test Engineer 9/3/2016
Franklin Lakes, NJ
JOB DESCRIPTIONAPPLY JOB TITLE: R&D TEST ENGINEER
LOCATION: FRANKLIN LAKES, NJ
* BS in Mechanical Engineering required.
* Experience creating engineering specifications and documents required.
* Experience creating medical device design control records (e.g., design requirements, verification and validation protocols, trace matrix, test reports, etc.) preferred.
* Track record of building mechanical systems, test fixtures, prototypes, models or similar systems is highly desirable.
* Familiarity with CAD design tools (Creo desirable).
* Familiarity with conventional mechanical test methods and equipment (e.g., Instron).
* Experience with dimensional measurement techniques and instruments desirable.
* Familiarity with basic statistical techniques is required.
* Ability to understand challenges quickly and organize multiple projects concurrently, and must adapt rapidly to changing work assignments
* Ability to organize and present large amounts of data in a clear and concise manner
* Excellent interpersonal, written and oral communication, and influencing skills
* Results driven and action oriented
* Careful attention to detail to ensure accurate and precise execution of work tasks and procedures
* Ability to work independently with minimal supervisor input, and able to communicate and discuss technical issues and significant findings of evaluations performed
* Disciplined and well organized in documentation in a regulated environment
* Knowledge of ASTM drafting standards including Y14.100 and Y14.5
* Experience with collecting, recording, and interpreting data
* Reporting to the R&D Manager and working closely with a dedicated cross-functional project team, the candidate will design and develop methods and fixtures for testing and inspection of medical device components.
* Candidate will be involved in creating verification and validation protocols and reports.
* The candidate must be aware of and follow Corporate and Divisional Qualitysystems and comply with all regulatory and safety guidelines.
* Specific responsibilities may include (but are not limited to) the following:
* Using 3D CAD design software, design fixtures for assembly, testing, and inspection, and work with internal or external services to manufacture fixtures
* Confirm product capabilities by designing feasibility and test methods and systems
* Evaluate new test equipment if required, and participate in the verification and validation of equipment performance
* Develop and conduct measurement systems analyses (gage R&R studies) on test methods and equipment
* Create, review, and revise detailed 2D and 3D CAD models, assemblies and drawings.