Duration: 12 Months
Location: Marlborough, MA
Job description:
• 5+ years experience
• Must have V&V testing experience, writing protocols/reports, experience with bioprocess technologies
The Development Engineer supports R&D’s Product Development with prototyping, testing and verification and validation of prototypes, components, and products. This role requires mechanical and technical aptitude, fundamental understanding of mechanical systems and testing, and ability to establish processes to assemble and test the components and products safely in a cross-functional environment. The Development Engineer is exposed to the full product development life-cycle, from requirements development through integration and testing.
• Create verification & validation test strategies for bioprocess technologies (bioreactors, mixers, consumable products), providing technical support and leadership with cross-functional teams.
• Execute testing and conduct analysis of the test results to ensure complete verification of the requirements and validation of product performance.
• Procure materials, build working samples, and test prototypes/products for use in the biopharmaceutical industry (e.g. Xcellerex bioreactors, mixers, single-use consumable bag/impellers).
• Conduct tests on mechanical systems, including our Xcellerex X-platform bioreactors, analyze results, and author reports.
• Analyze results, author reports, and present findings to project teams.
• Operate equipment using fundamental knowledge of best test and measurement practices, such as with environmental testing, aging studies, data acquisition, tensile/load testing, general evaluation, and measurement diagnostics.
• Generate, review and update the technical content of drawings, engineering specifications, reports, and other documents associated with the engineering process, and participate in formal engineering design reviews.
• Execute ECOs of products as designs are updated throughout the development lifecycle
• Provide feedback to the engineering team not limited to description of test methods, deviations from expected test results, and highlight of product non-compliances and risks.
• Engage in troubleshooting issues in the lab and work to resolution.
Who you are
• Bachelor’s degree in Biomedical, Chemical, or Mechanical Engineering, or related field
• 5+ years engineering experience in product development or bioprocess industry