POSITION SUMMARY:

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:

• Bachelor’s 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 & 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.