Design Control Specialist
C. R. Bard - Covington, GA

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The Design Control Specialist position is located at C. R. Bard Medical Division in Covington, GA.

Summary of Position with General Responsibilities:
This position is responsible to develop, track, manage, and update the division’s Design Control System and ensure compliance to the Quality System Regulation concerning Design Control for new product development (NPD). This individual will also play a key role in managing information across the entire R&D project portfolio, including front end idea tracking as well as sustaining engineering projects. Additionally, the Design Control Specialist functions as a subject-matter expert and resource on design control for the entire division.

Essential Job Functions:
Partner in the development, implementation and ongoing support of a new divisional design control system
Owner and ombudsman for division’s design control system for new product development:
Change and update procedures as required with changes in internal (Bard Corporate) and external (FDA, BSI, etc) environment
Proactively manage information within the design control system to organize design reviews, product releases and other major milestones
Manage assignment of training, including determination of who is to be trained in the system components
Facilitate the effort of developing and optimizing the commercialization process by a continual review of the Design Control system and other development related procedures.
Organize Design History Files for development programs.
Ensure products are produced in accordance with Corporate and Division product development policies.
Assist project members/leaders in preparing/assembling of (market) release documentation.
Assist project leader in the conduct of Technical Design Reviews

Partner in development of a front end idea tracking system:
Create and maintain portfolio management system for project idea generation (collecting both internal and external ideas)
Conduct monthly meetings to collect and prioritize ideas and projects within this system
Partner in development of Sustaining Engineering (SE) portfolio system:
Create and maintain portfolio management system for SE projects
Conduct monthly meetings to collect and prioritize ideas and projects within this system

Basic Qualifications:
  • Thorough 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 both new product development and sustaining engineering.
  • Knowledge of project-based product development and ability to work as a project member.
  • Excellent communication skills (written and verbal) with ability to influence.
  • Proficient in the use of a personal computer with intermediate level of keyboarding skills and proficiency in Microsoft Word, Microsoft Excel, Microsoft Power Point, Microsoft Project, Microsoft Access.
  • Strong interpersonal skills required in the areas of verbal and written communications, customer focus, telephone manner, 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
Education and/or Experience:
Minimum undergraduate degree (BS or BA) and a minimum 3-5 years experience in medical device or pharmaceutical industry. Engineering or related technical degree preferred.
Experience in Product Development is desired.
Experience in Quality Assurance is desired.
Experience with database management and/or information systems preferred.
Basic knowledge of human anatomy and physiology, hospital procedures and equipment.

Physical Demands:
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.

C. R. Bard - 19 months ago - save job - copy to clipboard - block
About this company
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C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...