C. R. Bard, Inc.

  • Sr. Manufacturing Engineer

    Posted Date 3 months ago(3 months ago)
    Industry / Category
    Medical Device
    Job ID
    2018-11726
    Career Level
    experienced
    Division
    Bard Peripheral Vascular
    Relocation
    No
    Location
    US-AZ-Tempe
  • Overview

    Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare.  BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

     

    We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

     

    Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world. #LI-JC1

    Summary of Position with General Responsibilities

    This is a high-level manufacturing engineering position for the third-party supplier and Tempe-related operations. This position is responsible for development of process improvements and validations of production processes.

     

    Requires a high-energy individual with excellent teamwork, partnering, and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development, quality and manufacturing experience. Responsible for the transfer of newly developed products to production.

    Essential Job Functions

    • 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 leads cross-functional teams.
    • Provides technical support on components, material methods, systems and equipment.
    • Writes and approves protocols, reports and data.
    • Manages testing outlined in protocols and test methods.
    • Manages/develops validation studies on equipment & processes.
    • Understands and follows company procedures and regulatory requirements.
    • Participates in and provides input to training on department & division procedures, and policies
    • Manages project planning, budgeting, scheduling and tracking.
    • Plans and coordinates engineering test builds.
    • Analyzes problems in design, process and test development. Recommend/implement solutions.
    • Prepares and presents oral and written project updates and technical discussions.
    • Develops and implements procedures/policy.

     

    Customer and Key Contacts: Tempe Manufacturing Facility employees, division New Product Development teams, BD Manufacturing Facilities, and external suppliers.

    Basic Qualifications

    • Excellent verbal and written communication skills.
    • Highly motivated, self-starter with the ability to achieve results with minimal direction.
    • Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
    • Design capability with small parts with an ability to read and understand mechanical drawings
    • Working knowledge of PTFE and other materials typically used in medical devices
    • Significant experience in product verification and validation testing, medical device new product development and rapid prototyping
    • Experience in product verification via test equipment development and equipment validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)
    • Strong proficiency in technical writing of protocols and reports
    • Proven capability in writing clear and detailed testing and product assembly procedures
    • Impeccable documentation skills and adherence to design control procedures and GLP
    • Demonstrated experience in application of lean manufacturing principles
    • Comfortable in a dynamic working environment with a high amount of change
    • Demonstrated ability in using statistical analysis techniques (i.e. Capability Analysis)
    • Demonstrated ability with solid modeling (i.e. SolidWorks)
    • Ability to make and present engineering decisions
    • Strong analytical and data skills (Excel VBA or other programming knowledge)
    • Demonstrated ability to be self-taught
    • Experienced with CAD (SolidWorks) and mold simulation (Moldflow, ANSYS, etc.)

    Education and/or Experience

    • Minimum Bachelor’s degree in an engineering field, Master’s preferred
    • Minimum of six (6) years experience within the medical device industry, or a Master’s degree and a minimum of five (5) years of engineering experience within the medical device or equivalent industry.

    Physical Demands

    While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 

    Work Environment

    Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
    While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

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