Senior Engineer, R & D
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We do have a Direct Client Requirement For the below position
TITLE: SENIOR ENGINEER, R&D
LOCATION: FRANKLIN LAKES, NJ
CONTRACT TERM: 12+ MONTHS
JOB TIMINGS: 8.00 AM- 5.00 PM
TRAVEL REQUIRED: 10%
* Minimum BS, preferably MS degree in Mechanical Engineering or related discipline with at least 3-5 years' experience in Medical Devices as a product design / development engineer
* Experience with implementing product changes through a structured, phase-gated Design Control process
* Experience with designing and developing disposable medical device products for high-volume manufacturing methods such as injection molding, automated assembly and packaging processes.
* Experience with design for different sterilization processes (autoclave, Ethylene oxide)
* Demonstrated execution of design verification and validations
* Demonstrated experience with all phases of the Design Control process in the context of FDA regulation and understanding of disciplined product development processes, regulatory and qualityrequirements for medical products Proficiency with one of the CAD design tools (SolidWorks, Pro/E, AutoCAD).
This position will contribute to design and development activities focused on developing and commercializing a new product. More specifically, the job responsibilities will include:
* Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions.
* Author protocols and reports for engineering, verification, validations studies using basic statistical methods.
* Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions
* Ensure appropriate processes are followed for effective and timely engagement of related parties in completion of designated project activities
* Use creative and critical thinking to devise new approaches to solve technical problems and leverage understanding of engineering principles, advanced engineering methods, data and judgment to support approach * Participate as a member of a cross-functional team to deliver R&D project commitments.
* Independently develop workplans for delivering on project commitments.