Statisticians will support functional areas with regard to proper implementation and execution of statistical techniques used throughout the lifecycle of a medical device.
• Responsible for revision of policies and procedures with regard to statistical techniques (Hypothesis Testing, Confidence Limits, Sample Size Determination, Design of Experiment, Process Capability, Measurement System Analysis, Acceptance Sampling, Statistical Process Control, etc.)
• Develop required training and participate in execution of training
• Support various production, engineering, quality, and technical teams in the evaluation of data and problem-solving
• Assist with design and execution of statistical analysis
• Approve protocols and reports as required by the quality system (i.e. independent statistical reviewer)
• Ensure that sampling methods are adequate for their intended use
• Communicate with non-statisticians on proper use of statistical methods and interpretation of results
• Develop and apply complex statistical techniques as needed and demonstrate the statistical validity of these techniques.
• Work effectively within teams and independently
• Effectively present and document complex subject material
• Critical thinking and attention to detail required
• May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)
• Manage conflict resolution as it relates to technical situations
• Work and interact effectively and professionally with and for others throughout various levels of the organization
• Perform work in compliance with Cook Quality System
• Maintain regular and punctual attendance
• M.S. in Statistics or above preferred, Bachelors or above in related scientific discipline may be considered with appropriate working experience
• Previous experience must include direct responsibility with application of statistical techniques within development and manufacturing role.
• Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
• Working knowledge of statistical software, experience with MiniTab preferred
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) preferred.
• Works under general office environmental conditions, including time in manufacturing environment
• Sitting for extended periods, utilizes close visual acuity for working with
computers, equipment, etc.
• Limited travel required