C. R. Bard, Inc.

  • Quality Engineer II - New Product Development

    Posted Date 1 week ago(4/9/2018 6:21 PM)
    Industry / Category
    Medical Device/ Design Quality Engineering
    Job ID
    2018-11086
    Career Level
    experienced
    Division
    Salt Lake City, UT/ Vascular Access Devices - MDS
    Relocation
    No
    Location
    US-UT-Salt Lake City
  • Overview

    BARD has now joined 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. 

     

    Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient’s vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.

    Summary of Position with General Responsibilities

    This position is responsible for conducting engineering studies for process improvements and validations. This position designs, develops and implements new products, processes, test methods and equipment for Quality.

     

    Quality Focus:

    • Develop sampling plans by applying attribute, variable, and sequential sampling methods. Develop local procedures, Test Methods, and standards.
    • Develop and implement Statistical Process Control.
    • Leads investigations related to quality problems.
    • Ability to define and manage risk-management plan, risk assessment and risk-control tools.
    • Independently lead or facilitate non-conforming product investigations, including corrective/preventive actions and product remedial actions.
    • Responsible for systems assurance including documentation, testing and inspection, and product and process development.
    • Will support Manufacturing, New Product Development, and Regulatory (as applicable) to ensure systems are in compliance with internal and external guidelines and regulations.
    • Proficient in statistical analysis and software.
    • Identify and lead product and systems continuous improvement initiatives.
    • Communicate effectively at all levels within Quality, as well as cross-functionally with R&D, Regulatory Affairs, Manufacturing, Supply Chain, Customer Service, Marketing, and other functions as necessary.
    • Able to influence decisions in a cross-functional team setting.
    • May mentor/supervise the efforts of an intern and/or technician.
    • Equipment Qualification Experience (IQ/OQ/PQ).
    • Execute design controls and analyzes design inputs.
    • May conduct/lead internal/external audits.

     

    QE-NPD Focus:

    • Lead and support new product development execution of design control from concept through post-launch phases.
    • Support design change activities through product lifecycle.
    • Lead execution of ISO 14971 compliant Risk Management processes and tools (e.g. FMEA, FTA).

    Essential Job Functions

    The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive.  The omission of a specific duty or responsibility will not preclude it from the position.

    • Consultant/ Department expert with technical expertise and business knowledge.
    • Organizational credibility and knowledge.
    • Guides and directs others within Department while being results oriented and a project Leader.
    • Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
    • Maintains a professional working relationship with internal & external customer and support staff
    • Participates and/or leads cross-functional teams.
    • Provides technical support on components, material methods, systems and equipment.
    • Develops physical and functional test requirements to assure specifications & regulations are met.
    • Writes and approves protocols, reports and data.
    • Oversees testing outlined in protocols and test methods.
    • Coordinates/develops validation studies on equipment & processes.
    • Executes design controls and analyzes design inputs.
    • Conducts complaints investigations.
    • Understands and follows company procedures and regulatory requirements.
    • Participates in and provides input to training on department & division procedures, and policies.
    • Prepares and submits for approval requests for project funding. Participates in project planning, budgeting, scheduling and tracking.
    • Plans and coordinates engineering test builds.
    • Analyzes problems in design, process and test development. Recommend solutions.
    • Prepares and presents oral and written project updates and technical discussions.
    • Develops and implements procedures to provide easy-to-follow instructions.

    Basic Qualifications

    • Bachelor degree in STEM (Science, Technology, Engineering, Math), and four (4) year of engineering experience within the medical device or equivalent regulated industry OR,
    • Masters degree in STEM and two (2) years of engineering experience within the medical device or equivalent regulated industry.
    • Demonstrated effective project management skills.

    The incumbent must demonstrate the potential ability to perform the essential functions of the job as outlined in the duties and responsibilities.

    Additional Desirable Qualifications Skills and Knowledge

    • Ability to make and present engineering decisions.
    • Ability to systematically manage multiple projects from initiation through closing phases. Projects include BAS and/or supplier resourced deliverables:
      • Determine and communicate project deliverables,
      • Develop a work breakdown structure and estimates,
      • Develop a viable schedule, management plans, and schedule,
      • Execute and control the project through closure.
    • Specific specialized engineering skills such as:
      • Create & critique engineering cost analysis,
      • Basic tooling design and drafting knowledge,
      • Analyze and optimize existing process and ability to create new processes,
      • Create, analyze and optimize manufacturing and quality systems,
      • Basic product, design & prototyping,
      • Material Science,
      • Bioengineering principles.
    • Ability to train, create and critique training; Strong interpersonal skills.
    • Ability to apply comparative statistics.
    • Software application skills.
    • Problem solving ability.
    • Ability to create, review and coordinate test protocols and reports.
    • Ability to generate engineering proposals.
    • Oral and written presentation skills.
    • Ability to lead cross functional teams.
    • Demonstrated ability to create and execute project plans.
    • Demonstrated Supervisory skills.
    • Ability to create and control a budget.

    Physical Demands

    This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching are also frequently required.

    Work Environment

    The ideal candidate must be able to work in a team oriented, fast paced environment.  Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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