C. R. Bard, Inc.

  • Senior Project Engineer

    Posted Date 3 weeks ago(9/21/2018 2:21 PM)
    Job ID
    2018-12311
    Career Level
    experienced
    Division
    UCC
    Relocation
    no
    Location
    US-GA-Covington
  • Summary of Position with General Responsibilities

    This position leads project teams and/or provides technical effort toward the remediation of technical documentation in support of product registrations in the European Union.  The position requires an understanding of medical device markets and regulations.  This position requires strong leadership and project management experience.  The candidate will lead cross-functional teams in an effort to remediate gaps to new EU MDR requirements.

    Essential Job Functions

    • As project leader guide team members through the EU MDR gap remediation projects. Projects will require: remediation to design documents, creation of rationales, creation of specifications, define testing protocols, labeling updates, and compliance with QSR requirements.
    • Manage complex project programs and sets direction for large technical efforts across multiple functional groups.
    • Leadership of external and cross-functional partners.
    • Understand EU MDR requirements and how to apply to new and existing technical documentation.
    • Develop plans and executes remediation activities according to project goals, timelines, and within budget.
    • Complete R&D department reports for Post Market Surveillance.
    • Present concise information as needed to Senior Management regarding progress of remediation activities according to timelines and commitments.

    Basic Qualifications

    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.

     

    • Detail oriented so that the candidate has the ability to organize multiple large work streams and coordinate using Visio or equivalent flow chart techniques.
    • Previous ability to construct and maintain project timelines through Microsoft Project.
    • Previous ability to organize, interpret, and draw conclusions with regard to large data set using Excel spreadsheets.
    • Strong interpersonal skills required in the areas of verbal and written communications.
    • Strong listening and assessment skills.
    • Strong questioning & problem-solving skills.

    Additional Desirable Qualifications Skills and Knowledge

    LANGUAGE SKILLS

    Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures or government regulations.  Ability to write reports and business correspondence.  Ability to communicate well with individuals at all levels within (and outside) the organization.  Any Spanish knowledge is a plus.

     

    MATHEMATICAL SKILLS

    Ability to perform basic engineering calculations and have understanding of design of experiment.  Also requires understanding of statistical concepts.

     

    REASONING ABILITY

    This position requires good judgment.  All product and process development activities within a team are to be carried out according to the applicable laws and regulations.  When in doubt, the incumbent should source out the appropriate information via internal and external resources.

     

    The incumbent will be a detail oriented individual with the skills to manage multiple priorities, projects and tasks all in support of corporate and divisional goals.

    Education and/or Experience

    • BS degree in a technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering or other engineering field is required.
    • Knowledge and training of project management, QSR, Device development and/or design control processes is required.
    • Minimum of 5 years experience in consumer/medical product and process development is preferred.

    Physical Demands

    While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear.  The employee will sometimes be required to move around in manufacturing facility or meet with medical professionals in hospital environment.  Specific vision abilities required by this job include close vision and color vision.

    Work Environment

    No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure), laboratory, and hospital settings.

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