Project Manager

ZOLL Medical Corporation, an Asahi Kasei Group company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, fluid resuscitation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat

Works with Program Directors and other individuals responsible for new product development, product line extensions and sustaining engineering releases to facilitate the scheduling, design, documentation, design history file development and ECO submissions associated with product designs and improvements. Oversees project risk management. Manages project requirements and traceability. Coordinates team review meetings. Works independently within project plans, budgets and schedules. Seeks supervision as needed to achieve project objectives.

50% Takes ownership of multiple projects. Works directly with engineering management, marketing and operations to facilitate the definition and documentation associated with product development including product specifications, product risk management, requirements management and traceability, budgets, schedules and resource commitments. Coordinates team meetings. 25% Recording secretary for all major design reviews associated with the product development effort. 25% Prepares and/or coordinates the preparation and submission of regulatory and engineering change order documents

* Thorough understanding of new product development practices including electrical, mechanical and software engineering issues and have the ability to implement projects outside area of expertise. * Demonstrated experience spanning: * Large cross disciplinary multi-year projects from concept to release * Product line extensions * Sustaining projects, such as manufacturing support and EOL. * Excellent written, verbal and interpersonal skills. * Must be capable of analyzing and solving complex problems through innovative thought and experience, as well as engineering and project management tools. * Must be self-motivated. * Demonstrated ability to successfully bring new high technology products to market * Knowledge of regulatory standards (i.e. EN 60601-1) applicable to medical device development including GMPs and FDA Guidelines. * Product Risk Management experience (ISO 14971) * Requirements Management experience (DOORs preferred) **Required Experience** * 7+ years R&D experience (medical device experience a plus) * 4+ years system level task leadership experience * BS degree in Engineering (Advanced degree preferred)