Project V&V Engineer
It is MEDRAD's mission to be a worldwide market leader of medical devices and services that enable or enhance diagnostic and therapeutic imaging procedures. MEDRAD performance is a result of an unrelenting commitment to improving healthcare, to upholding standards of excellence, and to responsible activities for the benefit of our customers, shareholders, employees, and communities. These values are expressed through our culture and philosophy, as well as our ethical and corporate responsibility policies. MEDRAD has over 1,700 global employees, 1,200 of whom are in the Pittsburgh area. MEDRAD's European headquarters office is located in Maastricht, The Netherlands. Our Asian headquarters office is in Osaka, Japan with additional international offices located in France, Germany, Italy, China, UK, Brazil, Norway, Belgium, Sweden, Denmark, Singapore, Egypt, Mexico, Cyprus and Australia.
Position Description:
This position manages the technical activities needed to accomplish objectives that support program needs. Specifically, this position will individually perform and lead other engineers/technicians in all aspects of verification and validation (V&V) activities for the MR Patient Care Program (Infusion, Wireless and Patient Monitoring systems). Primary Responsibilities:1. Performance and leadership of product development V&V for multiple MR Patient Care projects.2. Participates as a member of the Core Product Development Team and, along with V&V responsibilities, contributes to requirements development, safety risk activities, design reviews and regulatory submissions, during the entire product development life cycle. 3. Develops, executes and maintains product requirements trace matrix, V&V plans, procedures and reports.4. Manages V&V resources, including 3rd party test agencies, lab activities associated with project, V&V systems and scanner sites.5. Responds to deadlines and objectives.6. Builds and manages work plans.7. Influences trade-offs and decisions.Technical / Behavioral Requirements: 1. Seven years of experience in planning, designing and performing electromechanical system verification and validation. 2. Medical device experience and use of test equipmet for compliance with IEC 60601-series and related ISO, ANSI and AAMI standards preferred but not required3. Teamwork and leadership skills with a disciplined and structured approach for V&V. 4. Recommended 7+ years experience using relevant knowledge across a breadth of technical disciplines and applicable technologies with depth in some subspecialties.5. Bachelor’s Degree required, Master’s degree recommended. 6. Proven knowledge and understanding of clinical use cases7. Proven ability to perform on the Critical Path (per product development processes)8. Proven ability to interface design.9. Strong competency in Customer Focus, Driving for Results, Integrity and Trust, Ethics and Values and Compassion. 10. Proven ability to demonstrate at minimum, MEDRAD’s Supervisor competencies: Decision Quality, Developing Direct Repots, Motivating Others, Managerial Courage and Business Acumen.
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