Associate Design Assurance Director

Ensure efficient compliance to all applicable regulations through the implementation of a robust quality system and through communication/reporting to regulatory authorities. Your responsibilities will include: Manages both NPD, Sustaining and VIP activities with existing DA teams. Works closely with PMO to ensure the division is properly resourced to support projects Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. Builds strategic partnerships to further departmental and organizational objectives. Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills. Bachelor's degree (Engineering) Minimum of 5 years of Design Assurance Minimum of 5 years of leadership experience Master's degree (Engineering) Minimum of 5 years of supporting product development Minimum of 10 years' experience in medical devices Solid understanding of US and OUS regulations and requirements for product development Prior experience in Process Development, PMO, Reliability, Complaints handling Experience with complex capital equipment Experience with product that include Software or embedded firmware Experience with active implantable devices