Job Information
Meso Scale Diagnostics Llc Product Design Transfer Analyst in Rockville, Maryland
This position is responsible for the transfer of product, material, and process information from development/project teams for production release. This position works with cross-functional departments to ensure all product and document information is appropriately transferred from the development/project team for new and existing products in accordance with quality, manufacturing, and customer requirements.
DUTIES AND RESPONSIBILITIES:
Attend design reviews and other project related meetings
o Effectively communicate configuration considerations for product design
o Provide feedback on timelines and potential processing constraints
Work with development teams to fully define the scope of configuration activities needed for a project
o Coordinate with various departments and functional groups to ensure the accuracy of information provided by development team
o Communicate documentation issues and solutions to product development team
Generate documentation related to impact assessments and implementation preparation
o Generate Parts Maps for determination of impacts to existing product, determination of new product requirements, and assessment of the overall implementation plan.
o Prepare all documents required for Configuration (e.g. Bill of Materials (BOM), Routings, Product Specifications, etc.)
Support departmental training program and development of new tools
Ensure compliance to document and record control according to all MSD quality, ISO and regulatory requirements
Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS:
Bachelors degree in Science, Engineering or related field preferred
o Additional years of relevant experience may be substituted for a degree
Minimum of 3 years of experience working in a Manufacturing, Research and Development, Product Transfer, Quality or other related department is required
Minimum of 1 year of experience with product commercialization including hands-on work in quality assurance, manufacturing, product transfer, and/or product development strongly preferred
Experience in pharmaceutical, medical device or biotech industry preferred
Experience with Change Control and/or Document Control processes is required
Experience with ERP systems such as JD Edwards EnterpriseOne is desired
Experience with PLM systems such as Aras Innovator is desired
KNOWLEDGE, SKILLS AND ABILITIES:
Knowledge of product configurations and change management
Demonstrated ability to work independently under general supervision
Ability to identify and advocate for continuous improvement
Logical problem solving and demonstrated ability to organize and move tasks forward in an orderly and structured fashion
Excellent attention to detail and demonstrated ability to multi-task
Ability to work productively in a dynamic environment with changing priorities
Excellent oral, written communication and interpersonal skills
o Effectively communicate issues/problems and results that impact timelines for project completion
o Ability to interact professionally at multiple levels within a client-oriented organization
Proficient in MS Office
PHYSICAL DEMANDS:
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office
WORK ENVIRONMENT:
This position can be performed in a traditional or home office environment.