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US-MA: Engineer in Biotech

Date: 27-Dec-2011
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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

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BioTech FYI Center