Manufacturing Engineering Technician

About MaxCyte:

MaxCyte, the clinical - stage global cell - based therapies and life sciences company, uses its proprietary next - generation cell and gene therapies to revolutionize medical treatments and ultimately save lives. The Company's premier cell engineering enabling technology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licenses have been granted to more than 120 cell therapy programs, with more than 90 licensed for clinical use, and the Company has now entered into ten clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998, is listed on the London Stock Exchange (AIM:MXCT, MXCL) and is headquartered in Gaithersburg, Maryland, US. For more information, visit www.maxcyte.com.

Job Summary:

The New Product Development Manufacturing Engineering Technician works on the creation and assembly of low volume, high tech medical type devices in a project driven production working environment. The role provides operational support related to manufacturing , testing, shipping, and technical maintenance of instrumentation and software , including building of Instruments. Works independently. This individual reports to the Director of Engineering and Manufacturing.

Job Duties:

• Orders parts, assembles electrical and mech anical sub - systems, for building, testing, and shipping instruments.
• Participates in the installation, calibration, operational and performance qualification of the instrumentation systems
• Design s and builds fixtures and jigs to assist in inspection, assembly, and test and obtains quotes for cost of materials and labor.
• Write s test protocols and reports and preform IQ/OQ/PQ
• Work s with product develop engineering to support new product transfer from development to manufacturing. Create s all manufacturing documentation to support the release of a new product.
• Acts a s system expert - software user interface, instrument features, instrument messaging, error codes, etc..
• Provides training, technical support, and application customization at customer and/ or partner sites.
• Conducts all activities in compliance with Standard Operating Procedures and Manufacturing Batch Records outlined in MaxCyte's Quality Management System.
• Drafts and reviews procedures and work instructions for manufacturing and operat ions processes .
• Provides operational support and monitors assembly process control . Evaluates and recommends process improvements utilizing LEAN principles.
• Provides technical support to facilitate quality investigations, root cause analysis and correct ive action/preventive action (CAPA) implementation
• Initiates engineering change request s as functional change owner and oversees the execution and implementation of proposed change s.
• Supports internal and external audits and quality system certification
• A ssisting with other design and/or development activities.
• Complies with all applicable policies regarding health, safety, and environmental policies.
• Other responsibilities as assigned

Job Requirements:

• Bachelor's degree in Mechanical, electrical, Inst rumentation or Biomedical Engineering or other related discipline with at least 3-6 years of hands - on assembly and testing of instrumentation systems specific to medical devices and/or laboratory equipment; or 10+ years of relevant work experience.
• Mechan i cal design, SolidWorks
• Prior experience with software development / programming for customization of user interface is desirable.
• Demonstrated computer skills; experience using MS Office [Word, Excel, PowerPoint]
• Able to troubleshoot mechanical and electrical components and to confer with the Engineering to find the best ways to effectively manufacture parts, assemble (including processes) through completion of finished products.
• Customer oriented. Resolves customer problems and issues through technical expertise and troubleshooting
• Must be able to create work order instructions and have solid document control skills for new product development.
• Prior experience with LEAN manufacturing , Six Sigma principles and is highly desirable
• Possess a quality mindset and has experience interacting with Quality Departments related to vendor delivered parts. Working knowledge of QSR, GMP, and ISO requirements preferred
• Works effectively with a team as well as independently.
• Possesses stron g verbal, written and interpersonal skills and has a "do what it takes" attitude to meet customer deadlines
• Minimum travel - less than 10% MaxCyte, Inc. is an equal opportunity employer.