C. R. Bard, Inc.

  • Sr. Advanced Manufacturing Engineer

    Posted Date 1 month ago(7/2/2018 6:48 PM)
    Industry / Category
    Medical Device
    Job ID
    2018-11454
    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 Advanced Manufacturing Engineering (AME) position for the Tempe Operations facility. This position is responsible for new product process development and transfer into manufacturing.

     

    Requires a high-energy individual with excellent teamwork, partnering skills 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 process development, and manufacturing experience. Responsible for the transfer of newly developed products to production.

     

    Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

    Essential Job Functions

    1. Working as an integral member of pilot operations teams, developing manufacturing processes and transferring those processes into manufacturing.
    2. Be the development team expert in lean manufacturing and design for manufacturability.
    3. Analyzes problems in design, process and test development. Recommend/implement solutions.
    4. Develops and manages validation studies (IQ, OQ, PQ and test methods) on equipment & processes.
    5. Writes and approves protocols, reports, manufacturing procedures, test procedures and other documentation and tracks through appropriate approval cycles and implementation.
    6. Maintains a professional working relationship with internal and external customers and support staff.
    7. Participates in cross-functional teams.
    8. Provides technical support on components, material methods, systems and equipment.
    9. Manages test builds and testing outlined in protocols and test methods.
    10. Understands and follows company procedures and regulatory requirements.
    11. Participates in and provides input to training on department & division procedures, and policies.
    12. Manages, prepares and reports on project planning, budgeting, scheduling and tracking.

    Basic Qualifications

    1. Experience in the manufacture of implantable medical devices
    2. Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
    3. Design capability with small plastic and metal parts
    4. Ability to read and understand mechanical drawings
    5. Working knowledge of materials typically used in medical devices
    6. Significant experience in product verification and validation testing, medical device new product development and rapid prototyping
    7. Experience in product verification via test equipment development and process validation (IQ/OQ/PQ) within an FDA regulated or other regulated industry (i.e. bio-tech/pharma, aerospace, food/beverage)
    8. Proficient in technical writing of protocols and reports
    9. Proven capability in writing clear and detailed testing and product assembly procedures
    10. Impeccable documentation skills and adherence to design control procedures and GLP
    11. Demonstrated experience in application of lean manufacturing principles
    12. Comfortable in a dynamic working environment with a high amount of change
    13. Demonstrated ability in using statistical analysis techniques (i.e. Capability Analysis)
    14. Familiarity with solid modeling (i.e. Solidworks)
    15. Ability to make and present engineering decisions

    Responsible for generating equipment AFE’s and working within a budget

    1. New product manufacturing process development experience a must
    2. Experience with transferring medical product design and processes from development into large scale manufacturing
    3. Lean six sigma black belt desired

    Education and/or Experience

    1. Bachelors degree in science or engineering and a 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

    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. Bard Peripheral Vascular is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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