October 1, 2022 A Technology Blog

Job Opening for Senior Manufacturing Engineer in MaxCyte (22 Firstfield Rd, Gaithersburg, MD 20878)

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Job Category : Engineering
Company Name: MaxCyte
Position Name: Senior Manufacturing Engineer
Location : 22 Firstfield Rd, Gaithersburg, MD 20878
Job Description : Senior Manufacturing Engineer About MaxCyte: MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development, and commercialization of next-generation cell therapies. The company’s existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational research centers. MaxCyte has granted 16 strategic platform licenses to commercial cell therapy developers that allow for more than 95 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US. Job Summary: The Senior Manufacturing Engineer will oversee the design of assembly fixtures, tooling, and jigs and will identify and recommend solutions to production problems. Will also provide operational support related to manufacturing, testing, shipping, and technical maintenance of instrumentation and software, including building of Instruments. Works independently. Job Duties: Lead projects to justify, schedule, budget, develop, implement, and improve manufacturing systems, efficiency, and product quality. Orders parts, assembles electrical and mechanical sub-systems, for building, testing, and shipping instruments. Manages installation, calibration, operational and performance qualification of the instrumentation systems Machine mechanical parts (Machine shop experience) Work with Suppliers/Vendors to enhance the quality of parts and implement controls that measure critical to quality/function of components and assemblies. Designs fixtures and jigs to assist in inspection, assembly, and test Writes test protocols and reports and preform IQ/OQ/PQ Collaborate with product develop engineering to support new product transfer from development to manufacturing. Creates all manufacturing documentation to support the release of a new product. Acts as a 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 operations 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 corrective action/preventive action (CAPA) implementation Manage engineering change requests as functional change owner and oversees the execution and implementation of proposed changes. Supports internal and external audits and quality system certification Assisting 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, Instrumentation or Biomedical Engineering or other related discipline with at least 6-8 years of hands-on assembly and testing of instrumentation systems specific to medical devices, single use disposables, and/or laboratory equipment; or 12+ years of relevant work experience. Minimum of 3 years of project management or team leadership experience is required. Mechanical design, SolidWorks Demonstrated experience with software development / programming for customization of user interface. Demonstrated computer skills; experience using MS Office [Word, Excel, PowerPoint] Troubleshoot and resolve mechanical and electrical components Customer oriented. Resolves customer problems and issues through technical expertise and troubleshooting Working knowledge of manufacturing processes and design control Prior experience with LEAN manufacturing principles and is highly desirable Working knowledge of QSR, GMP, and ISO requirements preferred Team-oriented individual with strong verbal, written and interpersonal skills Has a “do what it takes” attitude to meet customer deadlines Minimum travel – less than 10% MaxCyte, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter to careers@maxcyte.com. Please reference Senior Manufacturing Engineer in the subject line.
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