| 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. |
