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.)
Lead cross-functional problem-solving efforts for Product Transfer/Change Control Activities
Identify process gaps and inefficiencies and provide recommendations for solutions
Support departmental training program and development of new tools
May lead and/or mentor others
Ensure compliance to document and record control according to all MSD quality, ISO and regulatory requirements
Write SOPs as needed
Specific duties may vary depending upon departmental requirements.

Bachelor’s degree in Science, Engineering or related field preferred
Minimum of 5 years of experience working in a Manufacturing, Research Development, Product Transfer, Quality or other related department is required
Minimum of 2 years 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
Experience with training or mentorship is desired

Senior Product Design Transfer Analyst

Key skills