494 System Engineer 3 Information Technology jobs in Arlington,VA

B.S. in Mechanical Engineering
5+ years of relevant experience in mechanical design in life science consumable, medical device, pharma, bioprocess components, or other regulated product development environments
10+ years for Level II
Direct experience designing single-use consumables and fluid control assemblies for cell therapy, gene therapy, bioprocessing, or sterile fluid handling systems
Experience with scaling up and high-volume manufacturing
Experience designing bioprocessing technologies such bioreactors, gas exchange, filtration, centrifugation, cell isolation, purification, process analytics, etc.
Strong understanding of fluid handling and fluid control systems, including tubing-based flow paths, pressure-driven flow, pumping, valving, and manifolds.
Experience integrating fluid sensing including bubble detection, pressure & liquid sensing, etc.
Experience with FEA preferred (e.g., COMSOL)
Experience designing for GMP manufacturing environments, including cleanroom-compatible use, contamination control, and sterile closed-system processing
Strong knowledge of materials used in GMP manufacturing systems
Experience designing complex mechanical systems, subsystems, and components
Experience designing fluid interfaces and sealing solutions including rotating fluid connections, dynamic seals, face seals, gaskets, and disposable-to-instrument mating mechanisms
Experience with DFx including manufacturing, assembly, reliability, usability, cost, etc.
Experience with tolerance analysis
Proficient in SolidWorks
Experience with SolidWorks PDM preferred
Experience with QbD principles, Design for Six Sigma (DFSS), Critical Parameters Design and Management (CPD&M) or similar
Working knowledge of Minitab for statistical analysis and Design of Experiments (DOE) preferred
Skilled in prototyping
Working knowledge of fabrication and assembly methods such as plastic injection molding, 3D printing, CNC machining, sheet metal forming, semi-automated & automated assembly, adhesives, conversion of films and foils, etc.
Working knowledge of metrology tools
Strong knowledge of Design Control (ISO 13485) and GMP compliance for cell therapy manufacturing environments
Familiar with ISO 9001, ISO 10993, ISO14971 and other relevant international safety and quality standards
Experience writing protocols, executing tests, overseeing outsourced testing, and writing reports
Knowledge of extractables/leachable, sterilization methods, particulate control preferred
Strong interpersonal skills with a track record of cross-functional collaboration, problem solving, and driving technical alignment
Excellent written and verbal communication skills
Travel 10-15% domestically