Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Project Manager, Labeling, MDR located in Covington, GA.
This position is responsible for directing the activities related to the execution of packaging and/or labeling projects within the sustaining engineering group within Urology and Critical Care. The position will be required to interface with all project stakeholders at UCC, including stakeholders at multiple sites (e.g. regulatory affairs, quality assurance, labeling, manufacturing, sourcing, etc.), to develop the appropriate timelines and ensure the assembled teams can successfully execute the assigned projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES; Other duties may be assigned.
• Act as the team leader for Packaging and/or Labeling Projects within UCC.
• Work with UCC management to assign appropriate resources.
• Responsible for team meetings (e.g., face-to-face, teleconference, and/or webinars) and generation of meeting minutes.
• Responsible for design reviews as needed.
• Responsible for communication of team objectives, charter, milestones and progress
• Owner of project status updates for Projects.
• Preparation of reports and presentations.
• Develop and track project budgets.
• Work with Finance to prepare project financial models, budget tracking spreadsheets and reports.
• Develop, assist in developing, and/or execute protocols and evaluations of products affected by design changes.
• Partner in continuous improvement of Packaging and Labeling Processes and Procedures.
• Help to identify stakeholders.
• Work with all stakeholders to build consensus on areas for improvement.
• Author new or modified procedures to address opportunities for improvement.
• Manage the research, scoping and execution of the electronic management of workflow.
• Ensure products are packaged and labeled in accordance with Corporate and Division product development policies.
• Travel based on project needs (e.g. to UCC facilities, conferences, etc.).
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/ or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Demonstrated project management skills or certifications.
• Knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development.
• Knowledge of corporate, division, and standard operating procedures, as they relate to Product Labeling and Sustaining Engineering.
• Knowledge of project-based product development and ability to work as a project leader.
• Excellent communication skills (written and verbal) with ability to influence.
• Proficient in the use of a personal computer with experience in Microsoft Word, Excel, Power Point, Microsoft Project, network systems (electronic mail) and Internet applications.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, time management, professionalism, coaching, influencing, and team building.
• Strong information management skills.
• Strong listening and assessment skills.
• Strong analytical thinking, questioning & problem-solving skills.
• Excellent organizational and time management skills.
• Ability to build and manage database systems for information handling and communication.
• Must be able to speak and write English fluently; must be able to communicate clearly and accurately.
• Must be able to understand legally and technically written standards, regulations, procedures, test methods so as to communicate their intent.
• Spanish language skills are desired.
• Minimum undergraduate degree (BS) in a technical or business management area and a minimum of three years experience in medical device or pharmaceutical industry.
• Demonstrated success in product development is required.
• Experience with project management systems (e.g. Microsoft Project) is highly desired.
• Prior knowledge of medical device packaging, labeling, labeling management software, UDI and MDR a plus.
Employee may be required to sit, bend, stoop, use keyboard, see, talk, hear, and walk and stand on concrete surface for extended periods. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This individual generally will work in an office environment with moderate noise and traffic.