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Senior Project Manager: Medical Device

Corporation in NY needs: Project Manager: Medical Device 5-10+ years of product development and project management experience in a medical device/pharma environment. PMP certification through PMI is a plus. Working knowledge in Microsoft Project. Prior applicable medical device product development experience. Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design Control RESPONSIBILITIES: Project Manager (PM) will be responsible for delivery and launch of orthodontic medical devices and services to the market via cross functional project team coordination while following Global Innovation Process. The scope and scale of projects will range from minor functional enhancements to breakthrough products and systems ranging from mechanical to technological in nature. New innovations may either be developed internally, or in collaboration with external partners and suppliers. The Project Manager will support various project teams consisting of a representative(s) from R&D, Quality Engineering, Marketing, Regulatory, Packaging, Purchasing/Supply Chain, Operations, Finance and Manufacturing. The PM will be responsible for organizing cross functional team activities which include project schedule creation, project meetings, publishing detailed minutes consisting of action items and deliverables, while monitoring progress against the schedule. PM will monitor team progress, ensuring that required technical interfaces to support the project are included to support the completion of project tasks and meeting project goals. Partners with Marketing, Clinical Development and Manufacturing functions to deeply understand the application and end use of family of orthodontic medical devices and services. Uses this understanding to be the Voice-of-the-Customer/business while interfacing with project teams and external partners. Aligns specific project(s) to the global product development strategy and ensures compliance to Global Innovation Process and divisional level procedures. Plans projects, directs and coordinates the efforts of engineers and non-technical project team members Conducts project meetings and design reviews. Publishes project action items and meeting minutes which track deliverables and open items. Develops and maintains program plans and communicate program status to management and internal teams. Drives to keep resources on task and on schedule, manage change, understand technical issues and ensure that they get prioritized, highlighted, addressed and resolved in a timely manner. Identifies and manages technical and schedule dependencies in the project and ensures that they are understood, planned for and executed against, appropriately. Provides regular updates to all Stakeholders on project status and progress being made Creates and maintains Project File/(DHF). Insures project deliverables meet global requirements (Regulatory, Corporate, Notified Body, etc., as required). Prepares project budget and forecast. Supports and participates with management during internal and external audits/inspections as needed. Identify innovation opportunities to add value to programs and products and provide value for our customer, beyond defined project scope and constraints Contributes to improvements in product development process Requirements: Graduate or undergraduate degree in Biomedical or Mechanical Engineering 5-10+ years of product development and project management experience in a medical device/pharma environment. PMP certification through PMI is a plus. Working knowledge in Microsoft Project. Prior applicable medical device product development experience. Working knowledge of ISO and FDA guidelines as they apply to Product Development/Design Control Should also possess strong leadership and team building skills, along with excellent organization, communication and interpersonal abilities. BS degree in Engineering (Biomedical or Mechanical) required. Master’s degree preferred. IMMEDIATE INTERVIEW! Base salary to 100K Please email your resume in WORD format and current base salary requirements ASAP: Darrenf AT rtijobs dot com  

Manhattan, Kansas