Description
Primary Function of Position:The Director of Validation Engineering is responsible for leading the team of validation engineers in defining and executing cleaning and sterilization validations in a cross functional setting for both new product designs and changes to existing products. The Director of Validation Engineering is also responsible for ensuring our reprocessing methods and procedures conform to the relevant national and international standards. He/she must be an effective, hands-on leader capable of prioritizing competing demands and crafting appropriate solutions for all of our internal and external customers.
Roles and Responsibilities:
Lead team of validation engineers and technical staff in defining and executing cleaning and sterilization validations in support of the definition, document creation, and field release of Reprocessing Instructions for Use (IFU)
Direct the definition, coordination, and release of reprocessing related customer facing materials Ensure consistent cross product family implementation of reprocessing methodologies to ultimately converge on a common approach for all products
Support Regulatory body inquiries - draft clear, simple explanations to non-technical audiences
Enable team based approach to validation activities by creating and maintaining guidance materials for teaching project engineers the basics of good cleaning, disinfection, and sterilization validation methods
Skill/Job Requirements:
Bachelor of Science degree or equivalent in Engineering or related physical science
10+ years of increasingly senior management experience with demonstrated cross functional expertise including conflict resolution skills and third party relationship management
Working knowledge of ISO 17664, 15883, AAMI TIR 12, TIR30, ISO 11135, ISO 11137, AAMI TIR 28 - knowledge of local international regulations a plus.
Strong understanding of medical device company manufacturing operations, GMP, and compliance requirements.
Strong track record of driving continuous improvement, both personally and within teams
Knowledge of engineering design control systems, e.g. Agile preferred
Superior written and oral communication skills
Ability to travel to customer or partner sites (10% to 15%), including international travel