Directs and participates in the activities of a system/software quality assurance function for complex medical devices. Directs and participates in the development of system and subsystem requirements for medical robotic systems and related elements, with particular focus on formal verification of system level requirements. Develops quality standards for company products and oversees the development and execution of system/software test plans and analysis of test results. Provides guidance in the preparation of technical appraisals of system architecture, software programming languages and systems, and related technology. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
- Assignments are in the form of objectives; determines how to manage resources in order to meet schedules and goals.
- Provides guidance to subordinates within established company policies and procedures.
- Actively manages project teams made up of both direct reports and representatives from supporting functions.
- Recommends changes to company policies and establishes procedures that affect immediate organization.
- Works on problems of diverse scope where analysis of situation or data requires an evaluation of a variety of factors, including current business trends.
- Resolves problems by selecting methods and techniques within the latitude of operational policies and processes.
- Advises subordinates and may perform related tasks to resolve technical problems and meet schedules.
- Develops and administers schedules and performance requirements; may have budget responsibilities.
- Manages and coordinates the activities of a section or department with responsibility for results, including costs, methods and staffing; may work through subordinate supervisors.
- Work closely with team members in adjacent disciplines including Mechanical, Electrical, Controls/Visualization, Software, Clinical and Test Engineering, as well as Quality Assurance, Regulatory Affairs and Manufacturing Engineering.
- Occasional interaction with Senior Management for technical and project presentations, and acting as an advisor.
- BS or MS in a related field.
- Requires 2-4 years management experience and 6 years experience in a related field.
- Background in Mechanical Engineering, Electrical Engineering, or Computer Science, with experience in complex system development. Experience in the clinical use of medical devices may also be relevant.
- Experience in medical device development, including a working knowledge of relevant FDA and International standards for medical devices.
Hansen Medical, Inc. is an Equal Opportunity Employer.