Manger of Validation

Job Description:
The Manager of Validation is responsible for the independent design validation of R&D products and the evaluation of staff performance, assignment of tasks, recommendation of training, and determination of staffing requirements. Will also review project documentation to develop test plans and strategies and requirements and design for testability. Develop, maintain, and execute validation test protocols. Assess, acquire and maintain test software and tools. Additional duties include: coordinating validation activities with project team members and managing processes and validation activities with Quality Assurance and Regulatory Affairs to ensure compliance with company, FDA cGMP, EN/ISO 13485, and MDD 93/42 EEC regulations.
REQUIREMENTS
The ideal candidate for this position must have a BS degree or higher in engineering or business administration along with a minimum of 8 years in development, verification and validation, or quality assurance of medical devices. At least 2 years of experience as a functional manager of design, quality, or test group is desired. Knowledge of product safety and regulatory agency requirements such as FDA, MDD, IEC, and ANSI/AAMI SW68 is a must. Proficiency in Microsoft Office is required. Must be able to prepare test protocols and reports and perform user Interface design and testing. Must know how to utilize common tools such as NI LabView, PVCS Tracker, Rational Requisite Pro, Test Director, or other defect tracking, requirement management, and test management tools. The ability to use laboratory test equipment such as logic analyzers, oscilloscopes, function generators, and data acquisition equipment is necessary. Excellent communication and organizational skills are essential along with being detailed oriented. Experience with software controlled electro-medical devices is preferred.

Company Info:
For more than two decades, Smiths Medical has produced medical devices that positively impact the lives of people worldwide. Our commitment to lead the industry in the development of infusion therapy devices to improve patient’s lives is evident in the quality products we have introduced to the market.

In addition to a career with a company dedicated to your success and professional development, we offer competitive salaries and generous benefits.

To apply online and for additional information, visit our website at
www.smiths-medical.com/careers www.smiths-medical.com/careers

Smiths Medical is an Equal Opportunity Employer
Drug Free Workplace/MFDV