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Senior Project Manager, Medical Devices

Apply Now Job ID R-361661 Date posted 03/05/2020

Locations

Covington, Georgia

Job Description Summary

Job Description

The BD Urology and Critical Care (UCC) division is seeking a Senior Project Manager for the Research and Development group.  This position is responsible for directing the activities related to the execution of new product development projects as well as sustaining engineering projects within BD UCC. The position will be required to interface with all project stakeholders at BD UCC, including stakeholders at multiple sites (e.g. regulatory affairs, quality assurance, labeling, 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 senior project manager for NPD and SE projects within BD UCC.
  • Work with BD 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 technical design reviews and phase gate reviews.
  • Responsible for communication of team objectives, milestones and progress
  • Owner of Planview project status updates.
  • Preparation of corporate and BD reports and new product development presentations.
  • Develop and track project budgets.
  • Work with Finance to prepare project financial models, budget tracking spreadsheets and reports.
  • Prepare and track required Authorizations for Expenditure (AFEs) for capital equipment purchases.
  • Develop, assist in developing, and/or execute protocols and evaluations of NPD and SE projects as needed.
  • Partner in continuous improvement of NPD and SE systems 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.
  • Ensure products are produced in accordance with Corporate and Division product development policies.
  • Assist Sales and Marketing in commercialization and launch activities.
  • Travel based on project needs (e.g. to BD facilities, conferences, etc).

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 

  • Has in-depth experience, knowledge, and skills in own job family. 
  • Applies knowledge and skills to a wide range of standard and non-standard situations. 
  • Works independently with minimal guidance. 
  • Usually determines own work priorities. 
  • Acts as a resource for colleagues with less experience

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.
  • Thorough knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development.
  • Ability to teach and educate others of these standards as they pertain to product development and design control.
  • 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 leader.
  • 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 Office.
  • Advanced experience with Microsoft Project.
  • 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.

EDUCATION and/or EXPERIENCE

  • Minimum undergraduate degree (BS) in a technical or business management area and a minimum eight years of experience in medical device or pharmaceutical industry.
  • Demonstrated success as a project manager within new product development is required.
  • Project Management certification preferred.
  • Experience with project management systems (e.g. Microsoft Project) is desired.
  • Experience in Marketing, Quality Assurance or Regulatory Affairs is desired.

LANGUAGE SKILLS

  • 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 to communicate their intent.

MATHEMATICAL SKILLS

Must have basic mathematical skills necessary for completion of validation/qualification requirements, and a basic knowledge of statistical analysis.

REASONING ABILITY

Generally, written rules, precedents and policies to determine or guide decisions are existing and accessible. Judgment calls will be made by this individual based on experience, education, and all available facts, since each project is unique. The individual must be able to initiate learning and decision-making without much initial information. This position is unique to Product Development projects in that the individual must understand all project members’ functions and how each role interacts with the rest of the project activities.

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.

WORK ENVIRONMENT

This individual generally will work in an office environment with moderate noise and traffic.

Basic Qualifications:

A minimum of 5 years experience monitoring and managing investigational sites

Prior experience leading professional staff in a clinical research environment preferred

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

LI-TECH

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com