Date: 27-Dec-2011
To see other BioTech job opportunities,
please visit http://biotech.fyicenter.com/
R&D Engineer in Biotech
* Participate in the design and testing of Product Requirements, Design Specifications and Design Descriptions for assigned projects, as required by applicable medical device or biologics standards and internal procedures
* Design robust assays to evaluate key desired properties (e.g., identity, purity and potency) of the product(s), and continuously revisit/optimize production processes, if necessary, to assure the consistence of these properties during various stages from pilot study to manufacturing
* “Hands-on” capability to fabricate, assemble and test prototype models and fine-tune designs until they are ready for production
* Create and test new product designs and formulate manufacturing specifications
* Interact with manufacturing resources to design for manufacturability, reliability and cost-effectiveness
* Execute experiments to test tolerances and other factors during the developmental process
* Analyze and interpret data from experiments to drive development projects forward
* Document and present results on development status at project team meetings
* Support manufacture transfer of product/process by generating the appropriate technical data to demonstrate product performance
* Prepare and deliver specifications and procedures in the standard forms (e.g., SOP) to manufacturing team for the technology transfer and production
* Generate creative solutions to advance multiple product development projects
* Perform mammalian cell culture/cell banking processes
* Demonstrate a broad array of analytical skills such as extracellular matrix protein analysis, ELISA, fluorescence labeling/imaging, colony forming assay, flow cytometry, mechanical analysis, and histological analysis
* B.S. in Mechanical Engineering or Chemical Engineering or Biomedical Engineering (M.S. preferred) and 2+ years industry experience in related medical device, cell therapy and/or manufacturing
* Experience with FDA design controls or similar regulatory environment (QbD)
* Expertise/knowledge of GMP for FDA medical devices and/or biologics
* Very strong interpersonal & verbal/written communication
* Strong skills in statistical analysis (JMP, SAS, SPSS), DoE (Design Expert)
* Strong computer skills including MS Visio, MS Project, MS Office
* Excellent organizational skills; note taking and communication skills; ability to work in cross-functional teams; attention to detail; good time management
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
