C. R. Bard, Inc.

  • R&D Engineer II

    Posted Date 8 hours ago(8 hours ago)
    Industry / Category
    R&D Engineer
    Job ID
    2018-11633
    Career Level
    experienced
    Division
    New Hope, MN/Lutonix
    Relocation
    No
    Location
    US-MN-New Hope
  • Overview

     

    Trailblazing Innovation for Patients

    BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.

    Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products.  Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients.  Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.

    Summary of Position with General Responsibilities

    The indiviual in this role will develop, optimize, and validate drug coated balloon manufacturing processes. The candidate will conduct process development activities to understand process inputs, outputs and relationship of inputs and outputs. The candidate will perform hands-on testing in optimization of coating formulations, coating processes, balloon folding processes, and product drug release. The candidate will write process validation protocols/reports, prepare work instructions and standard operating procedures, conduct process qualification and validation, support equipment development, and support other activities from R&D, Quality, Operations, and Regulatory Affairs.

    Essential Job Functions

    • Develop and optimize manual and automated manufacturing processes.
    • Perform lab bench testing and pre-clinical testing to characterize process output(s).
    • Set-up manufacturing and/or test equipment and perform process and product tests.
    • Investigate the effect of process inputs on both quality and yield.
    • Conduct process development activities and compose technical reports
    • Determine key process inputs and outputs of manufacturing processes including solution preparation, balloon coating, and balloon folding.
    • Establish correlation between process inputs and process outputs using statistical methods (such as DOE) and/or oversee test execution with minimal supervision.
    • Prepare work instructions and standard operating procedures.
    • Build test parts for engineering evaluation and pre-clinical studies.
    • Prepare process validation protocols/reports and oversee in execution of validation building/testing.
    • Support new equipment development, including specification development, vendor selection, and negotiation.
    • Generate and communicate project strategies and scenario plans to management.

    Additional Desirable Qualifications Skills and Knowledge

    • Experience with balloon catheters, stents and stent delivery systems preferred.
    • Experience leading small cross-function process development teams.
    • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.
    • Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment.
    • Training in Six Sigma or Design for Six Sigma. Ability to analyze data, interpret results and write reports. Proficient in statistic software, such as MiniTab, is a plus.
    • Demonstrated problem solving skills and hands-on technical aptitude
    • Excellent oral and written communication skills
    • Knowledge of cGMP and GLP is a plus.

    Education and/or Experience

     

     

    • B.S. degree in Biomedical Engineering, Mechanical Engineering or related engineering discipline.
    • 4 or more years of engineering experience
    • 2 or more years of experience in R&D or process development
    • 2 or more years of medical device experience 

    Physical Demands

    While performing the duties of this job, the employee may be required to stand, walk, sit, wear personal protective equipment, and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.

    Work Environment

    While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast­ paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

    This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

     

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