Senior Mechanical Engineer

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 licences have been granted to more than 1 4 0 cell therapy programs, with more than 100 licensed for clinical use, and the Company has now entered into twelve 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 Senior Design Engineer researches, plans, designs , develop s and validates life science Instrumentation , Disposables, and assembly processes and equipment. The Senior Design Engineer generates and implements ideas/concepts for new product s and is involved in every aspect of instrumentation and disposable development and manufacture to meet the needs of customers, scientists, and clinical partners.

Job Responsibilities:

• Responsible for all aspects of product development including: product definition, technical specification, documentation, product design, product manufacturing integration, and qualification/validation.
• Reviews design information and specifications to determine critical to quality parameters of design.
• Design s for manufacturing (DFM). Develop s products considering maximum variation needed to mass produce using manufacturing automation .
• Statistically analyze variable and attribute data to support process development and validations (PQ)
• Develop s assembly processes for disposables that are flexible and can be scaled to meet high annual volume s and high mix disposable product lines .
• Create s product development documentation to support the design controls stage gate process and m eet GMP requirements .
• Works with R& D to evaluate product prototypes, performance, and design features.
• Conceptualizes novel configurations for products.
• Supports lifecycle of Engineering Change Controls.
• Ensures development efforts for products are effectively transferred to manufacturing.
• Work s with suppliers with respect to specifications and fabrication and purchasing components and subsystems.
• Supports , as needed , technical investigation s pertaining to MaxCyte products.
• Applies design and manufacturing strategies to meet project objectives and ensures design outputs meet requirements.
• O versee s development activities of outsourced vendors
• Project manage s , create s, and maintain s Gantt chart s . L ead s project meetings and publish es meeting minutes.
• Creates mechanical drawings for fabr ication of mechanical components.
• Establishes and maintains engineering standards and procedures.
• Complies and adheres to all Company health, safety and environmental policies.
• Other duties as assigned.

Job Requirements:

• B.S. in Mechanical or Biomedical Engineering and 5 - 8 years of experience designing prototypes and products for manufacture; or equivalent. MSME Preferred
• Instrument and disposables design experience in life sciences or medical device industries preferred.
• Six Sigma Black Belt certifi ed (DMAIC) with 2 - 5 years working experience in an R&D and manufacturing environment
• D emonstrated experience in the product development process, from design conception through final approval. Disposable design and assembly process development experience highly desirable.
• Solid understanding of mechanical design principles and the ability to independently perform complex problem solving.
• Hands on experience with design control and change control.
• Proficient with CAD software (Solidworks, AutoCAD).
• Demonstrat ed p roject management experience. Formal PMP trained desired.
• Familiar with international quality and safety regulations including cGMP, ISO9001, and/or IEC 60601 -1 and 61010
• Strong oral and written communication skills.
• Strong organization and time management skills
• Ability to work effectively in team environment as well individually.
• Demonstrated ability to be creative and willing to contribute to areas outside of personal expertise .
• Ability to travel 10 - 15 % MaxCyte, Inc. is an equal op portu nity employer.