Test Engineering Manager
Our client is a growing company working with world-class partners to develop unique and disruptive therapies that will have an immediate impact, saving lives on a global scale.
The Test Engineering Manager role involves quality & test advocacy, resource planning & management, and resolution of issues that impede the testing effort. The Test Engineering Manager is responsible for test plans, test scripts, test execution, defect tracking & maintenance, and maintains technical documentation while interacting with development, test team, and project stakeholders.
· Manage all testing activities
· Staffing, motivating and leading a highly effective testing team
· Define the scope of testing within the context of each project, release or upgrade by providing project high level verification plan
· Planning, deploying and managing the testing effort for any given engagement, conduct statistical analysis of test results
· Apply the appropriate test measurements and metrics for the product and the organization
· Bachelor of Science in applicable engineering field; Master is preferred.
· 10+ year’s medical device development experience (class II or III) is required along with a solid working knowledge of ISO 13485, IEC 60601-1-1 -2 -6 -8, IEC 62304, ISO 14971, FDA Quality System Regulations, and EU MDD/MDR
· 5+ years people management experience of a technical team, mentor experience is desired
· Demonstrated ability as a strong team player with cross functional peers
· Knowledge of additional standards applicable to the development of medical devices is highly desired (i.e. IEC 60529, ISTA, IEC80601-2-12, IEC 60068-2-64, IEC 60721-4-7, ISO 10993, EU Directive 2012/19/EU, HIPAA etc.)
· Strong design control and documentation skills
· Experience with respiratory equipment is a plus
· Class 3 medical device NPI experience is desired. Knowledge of FDA PMA process is desired.
· Automation test tool development experience is a plus
Equal Opportunity Employer