Manager, TruDi(R) Calibration Systems

Changing lives. Building Careers.Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.We are seeking an experienced Manager to lead the team responsible for the development, life cycle management, and global service support of Testers and Calibration (T&C) systems used in the manufacture of TruDi Navigation Systems and related products. This role is critical for ensuring the effective management of all T&C systems, providing strategic direction, and aligning resources to meet both internal and external customer needs.Key ResponsabilitiesNew Product Development for T&C systemsEnd to end responsibility for the development of new Testers and Calibration systems, from receiving the requirements from the customers, until the system is released and installedLife Cycle Management for T&C systems projectsResponsible for all Eng. and project activities supporting the Life Cycle of the testers & Calibration systems, including EOL managementTechnical support for improvements, investigations and problem solvingT&C ServiceSupport all TruDi manufacturing sites for T&C systemsInstall base management for all Testers & Calibration systems worldwideInstall base data control and data management systemsConfiguration controlProject Management for Testers & Calibration systemsResponsible for the execution of all projects managed by the teamLeading project teams / core teams as requiredBuild project plans, budget and timelines. Track and meet milestonesLead project meeting, action items, resources management, and supplier issues.Business Partners/Suppliers managementBuild commercial relations with Tester & Calibration systems suppliersBuild agreements, contracts, SOWs and POs to support R&D and LCM activitiesActs as the commercial point of contact for our Testers & Calibration systems business partnersLeads the long terms strategy for Testers & Calibration systemsManages the roadmap for all activities required to support company Testing & Calibration needsEstablish, manage and communicate priorities and status for Calibration team projects to Integra’s leadership team and within the organization.Engages with internal and external teams to represent T&C in long term planning activitiesResources management (Manpower, suppliers, Hardware, systems, etc.) to support all R&D and LCM activitiesTesters & Calibration systems department leadershipDirect management of the Team leader in the departmentManage the professional development and career progression of engineers and technicians on the teamCollaboration with all other managers in the Eng. team.Represents the Testers & Calibration system department in the Eng. ManagementResponsible for communicating business related issues or opportunities to next management levelResponsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicableResponsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and proceduresQualificationsExperience in HW Eng/System Eng/Project management with a good understanding of complicated multidisciplinary systems. Familiarity with several Eng. Fields and disciplines.NPI leadership and track record or developing and introducing products to marketLCM Engineering and track record of sustaining existing products in the marketAt least 3 years of direct management experience of technical professionalsExperience in a Medical device company or other regulated industryKnowledge of GMPs, ISO 13485 Design Control, and manufacturing process qualification requirements for medical devices is strongly preferredSeveral different Eng. or R&D/Operations positions preferredExperience in managing relationships with external suppliers and OEMs is requiredExperience in managing subcontractors in the development of hardware and software-based systemsStrong communication, team building, and cross-functional coordination skills are requiredAbility to travel up to 15% domestic and international is required