Senior Staff Reagents Development Scientist
Senior Staff Reagents Development Scientist
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Job Description
Overview
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.
Responsibilities
- 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
Qualifications
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%.
Required Experience:
Staff IC
Employment Type
Full-Time
