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R&D Research Engineer


  • Azzur IT
  • 05/24/19
  • West Chester, PA
  • 19380
  • 75 / Hourly
  • Contractor
Our client, a Life Science leader, offers a long-term contract assignment for a R&D Engineer for design and development of new implants and instrumentation and/or support in-market products through their product life-cycle within multiple cross-functional project teams (e.g., Medical Affairs, Regulatory Affairs, Quality, Manufacturing, Marketing). This includes the design and development aspects of complex systems and projects, technically leading cross-functional project teams through all phases of the product life-cycle, and will often organize, plan, execute and oversee projects through product launch, commercialization, and post market surveillance. Key responsibilities include:

Solve complex design problems utilizing CAD techniques, rapid and conventional prototyping and other available technologies. Generate design concepts and prototypes independently.
Perform design evaluations (such as tolerance analysis, FEA, simulated use testing, dry labs and wet tissue labs etc.) Document clinical and surgical technique observations to create meaningful design solutions.
Development and execution of design verification and validation plans and activities, and test plan formation and execution to support global regulatory strategy.
Collaborate with manufacturing engineering and/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes and supporting production documentation
Advise on the application of design controls and development processes, and support the project leader with aspects of the project management functions including scope definition, and contingency planning.
Perform complaint investigations and field/quality investigation activities in support of patient/customer safety including audits, remediation projects, non-conformances, and regulatory compliance projects.
Support Operations projects associated with Cost Improvement Projects and Production Transfers.
Performs other special projects and functions as assigned.

Qualifications
A minimum of six years of experience in the design and development of medical devices, mechanical products, or biomechanical systems, including multi-component systems. Experience in medical device industry and knowledge of Regulatory Design Controls is highly preferred.
BS in Mechanical Engineering, Biomedical Engineering, or equivalent required; Master's degree preferred.
Strong experience with CAD software (Pro-E, Creo, Solidworks, etc.) along with demonstrated creative design ability.
Effective communication and interaction skills, with the ability to interface with individuals from various functions and to effectively communicate concepts, ideas and knowledge to individuals, customers and/ or teams, and work effectively as a technical leader and sometimes as a project leader.
Effective organizational skills to support all aspects of the project management functions and strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience
Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint, etc.)


Employer Information

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