The Senior Staff Reagents Development Scientist will leverage Designing for Six Sigma (DFSS) tools and principles to drive robust product design/development.  This individual will employ advanced experimental design principles (e.g., DOE) to optimize reagent formulations.  In collaboration with Operations/Product Support and System Engineering, this individual will ensure formulations are robust to manufacturing tolerances and system noise(s). This individual will serve as a DFSS champion and mentor.

• Applies established DFSS principles and tools to new product development in the Hemostasis and Acute Care Business Unit
• Drives formulation optimization in collaboration with the R&D project teams
• Drives critical parameter management studies for new products
• In collaboration with the R&D project teams and Medical Affairs/Clinical, designs and executes Monte Carlo simulations to predict clinical performance against predicates/reference tests
• Frequently communicates project status to stakeholders and across organization.
• Champions and mentors junior scientists on the use of DFSS tools/principles
• Assist in formulation optimization when design changes are required for on-market Hemostasis products
• In collaboration with the R&D and product support team, assist in QC method development for new products
• May direct the work of other personnel.
• Performs other related duties and responsibilities as assigned.
• Reasonable accommodation may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

• Responsible for cross-functional collaboration to identify and implement technical solutions for new product development, sustaining, and life cycle management products.
• Frequent inter-organizational and outside contacts. May represent the company to outside organizations on technical issues

Skill and Capabilities

• Technical leadership, problem solving skills, effective time management, effective in building cross-functional relationships and effective communication.
• Experience in statistical analysis, exploratory data analysis, and data representation
• Experience applying DFSS/DMAIC methodologies to design and develop new in vitro diagnostic platforms
• Strong presentation and general communication skills, ability to work in teams

Minimum Knowledge & Experience for the position:

• Minimum of a BS degree, MS or PhD preferred.
• DFSS green or black belt certification required.
• Minimum of 10 years work experience in IVD product development

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Travel Requirments

• Up to 5%.