Mechanical Engineer

Location
Gaithersburg, MD, United States
Posted
Nov 17, 2020
Ref
690654875
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 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 Mechanical Engineer researches, plans, designs and develops life science consumables for its instrumentation product line. This position contributes to every aspect of consumable development and manufacture to meet the needs of customers, scientists, and clinical partners. The Mechanical Engineer generates and implements ideas/concepts for new product development and sustaining engineering for instruments and consumables .

Job Responsibilities:

• Responsible for aspects of product development including: product definition, technical specification, product design, protocol/report documentation (i.e. Design History File) , product manufacturing integration, and qualification/validation , under the direction of senior staff .
• Develop s detailed assembly processes and inspection procedures, semi - automated assembly fixture that produce a high - quality end product with repeatability .
• Identif ies t he critical to quality/function dimensions based on functional requirements.
• Create s realistic and executable detailed project gan t t charts and timelines that capture critical path .
• M easur e s complex part geometries using calipers , gage pins, optical comparator , and other complex metrology instruments.
• Ensures design efforts are oriented to product scale up and mass production.
• 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 interfaced with manufacturing sources.
• Work with suppliers with respect to specifications and fabrication and purchasing components and subsystems.
• Supports as needed technical investigation pertaining to MaxCyte products.
• Applies design and manufacturing strategies to meet project ob jectives and ensures design outputs meet requirements.
• May oversee development activities of outsourced vendors.
• Creates mechanical drawings for fabrication of mechanical components.
• Establishes and maintains engineering standards and procedures.
• Obtains w orking knowledge of QSR, GMP, and ISO requirements.
• Complies and adheres to all Company health, safety and environmental policies.
• Other duties as assigned.

Job Requirements:

• B.S. in Mechanical Engineering and at least 3 years of experience designing prototypes and products for manufacture; or equivalent.
• Specialized experience in life sciences or medical device industries preferred.
• U nderstanding of mechanical design principles and the ability to independently perform complex problem solving.
• Working knowledge of assembly methods, such as ultrasonic plastic welding, RF welding, adhesives, friction fits, and fasteners a plus
• Hands on experience with design control and change control.
• Proficient with Solidworks CAD software.
• 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 opportunity employer.