Product Design Transfer Analyst

Meso Scale Diagnostics, Llc. - Rockville, MD

Full-time

Rockville, MD

Computer and Electronic Product Manufacturing

About the position

The Product Design Transfer Analyst is a critical role responsible for the seamless transfer of product, material, and process information from development and project teams to production release. This position plays a vital part in ensuring that all product and document information is accurately conveyed from the development/project team for both new and existing products, adhering to quality, manufacturing, and customer requirements. The analyst will collaborate with cross-functional departments to facilitate this transfer, ensuring that all necessary documentation and information are in place for successful product commercialization. In this role, the analyst will attend design reviews and other project-related meetings, effectively communicating configuration considerations for product design. They will provide feedback on timelines and potential processing constraints, working closely with development teams to fully define the scope of configuration activities needed for each project. Coordination with various departments and functional groups is essential to ensure the accuracy of information provided by the development team, and the analyst will be responsible for communicating any documentation issues and proposing solutions to the product development team. Additionally, the analyst will generate documentation related to impact assessments and implementation preparation, including creating Parts Maps to determine impacts to existing products, new product requirements, and the overall implementation plan. They will prepare all necessary documents for Configuration, such as Bill of Materials (BOM), Routings, and Product Specifications. Supporting the departmental training program and the development of new tools is also part of the role, along with ensuring compliance with document and record control according to all MSD quality, ISO, and regulatory requirements. Specific duties may vary depending on departmental needs, making adaptability and a proactive approach essential for success in this position.

Responsibilities

• Attend design reviews and other project related meetings.
• Effectively communicate configuration considerations for product design.
• Provide feedback on timelines and potential processing constraints.
• Work with development teams to fully define the scope of configuration activities needed for a project.
• Coordinate with various departments and functional groups to ensure the accuracy of information provided by development team.
• Communicate documentation issues and solutions to product development team.
• Generate documentation related to impact assessments and implementation preparation.
• Generate Parts Maps for determination of impacts to existing product, determination of new product requirements, and assessment of the overall implementation plan.
• 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.

Requirements

• Bachelor's degree in Science, Engineering or related field preferred; additional years of relevant experience may be substituted for a degree.
• Minimum of 3 years of experience working in a Manufacturing, Research & 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.

Nice-to-haves

• 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.
• Ability to interact professionally at multiple levels within a client-oriented organization.
• Proficient in MS Office.