R&D Engineer I/II Job in Canton 02021, Massachusetts US
RD Engineer I/II
The RD Department at Organogenesis is looking for a highly motivated individual to join the Development team as a key contributor in a cross-functional environment. The key project areas include the generation of feasibility and pre-validation data during the development of cellular-based products for oral regeneration and bio-active wound healing therapeutic applications. Candidate will also provide strong technical support to process engineering and development, validation efforts, and FDA submissions and facilitate technical transfer into steady state manufacturing. The candidate will work effectively with cross-functional, multi-leveled, and interdisciplinary project teams to achieve project goals.
KEY RESPONSIBILITIES
- 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
Within this broad framework we are less focused on one particular skill, rather we are more interested in an individual who has demonstrated the capacity to adapt and show a strong desire to learn new concepts and techniques.
Job Requirements:
PREFERRED EDUCATION AND EXPERIENCE
- 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