Program Manager

Location Fremont, CA Description Our client is currently seeking a Program Manager for a 12 month + contract. DescriptionComment Manages multiple projects and orchestrates the results to achieve a broad program goal. Plans and implements schedules and monitors program from inception through delivery. Defines and reports program roadmap, status, development issues and success metrics. Identifies and monitors areas of risk. Continuously seeks opportunities to improve cost, performance and schedule. Builds and manages to budgets. Facilitates communication and coordination among projects. Manages stakeholder engagement and satisfaction. Maintains awareness of trends, business conditions and internal process and practices impacting component projects or overall program. Additional Job Details MDR Program Manager February 2021-February 2022 JOB SUMMARYDESCRIPTION A Program Manager to manage changes to PackagingLabeling to meet EU MDR requirements, and cross-functional work-streams for the preparation of EU-MDR and US submissions. The primary work will be to adaptdevelop redesigned labeling collateral across the business portfolio. May lead revision of Quality System documentation to maintain governance compliant with EU-MDR. The scope of work includes the integration of some products into an established, highly automated eIFU system as well as the integration of information within a patient-accessible website that has electronic documentation for patients per EU MDR. ADDITIONAL JOB DETAILS Leading cross-functional teams in the development of formalized plans, ensuring new content undergoes rigorous review and aligns with EU MDR regulations, and meeting implementation -readiness milestones Defining realistic program and project goals, objectives, and metrics in a highly matrixed organization Working with lead MDR Program Manager to identify and garner the necessary resources to execute the project Working with Tech Pubs group and manufacturing operations teams for implementation Developing and refining SOPs and Work Instructions Managing programproject risk (identification, contingency and mitigation planningmanagement) Leading activities to resolve issues and reach effective decisions in a timely manner Driving execution of program and project deliverables through others and self, ensuring that the products and project deliverables meet rigorous standards of quality QUALIFICATIONS BS degree (engineeringtechnical) with 9 years experience in an engineering or technical field (including at least 5 years in new product development), or equivalent. Medical device industry experience, preferred. Five years experience in project management including demonstrated experience in all project management processes. Project Management Professional (PMP) certification, preferred. Breadth across various project types (for example, new device development, design change implementation and launch into existing markets, coordinating with IT project teams), a plus. Demonstrated o Knowledge of development life cycles and project management tools o Ability to build, energize, and lead teams formed from a cross-functional, matrixed organization and promote teamwork o Ability to lead cross-functional groups in technical risk analysis, problem solving and decision making o Ability to communicate effectively at all levels within an organization o High performance in personal abilities commitment to task, tolerance of ambiguity o Effective written communication skills o Commitment to quality for own and team deliverables, with well-developed attention to detail. o Ability to map processes o Experience in utilizing strict document control systems. Highly preferred experience in PTC Windchill Document Management System. Experience in developing products and Quality System documentation requiring regulatory approvals, preferred. Ability to travel to observe pilot runs, preferred. Experience in typical tools for planning and communication Excel, MS Project, PowerPoint, Visio Contact mailto?subjectProgram20Manager This job and many more are available through The Judge Group. Find us on the web at www.judge.com httpwww.judge.com