C. R. Bard, Inc.

  • Senior Quality Engineer

    Posted Date 3 months ago(3 months ago)
    Industry / Category
    Medical Device/ Quality
    Job ID
    2018-11716
    Career Level
    experienced
    Division
    Bard Peripheral Vascular
    Relocation
    TBD
    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 position develops implements and improves commercial product quality requirements.

    This is a high-level quality engineering position.  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 / manufacturing experience in product and process development. 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.

     

    This candidate must be able to travel up to 40% of the time.

    Essential Job Functions

    • Provide Quality Engineering support on Product Engineering Teams.
    • Provide on-going support to manufacturing site(s) for commercially available products
    • Initiate new or revised documentation
    • Lead cross-functional teams to develop risk assessment for proposed changes to commercially available products (i.e. material / spec changes)
    • Lead periodic product franchise reviews.
    • Develop physical and functional test methods to ensure specifications are met.
    • Write, review and approve design verification and validation protocols and reports.
    • Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.
    • Conduct and /or coordinate testing outlined in protocols and test methods.
    • Perform process improvement, control and monitoring on manufacturing processes.
    • Participate during design transfer activities.
    • Conduct complaint investigations.
    • Participate and provides input to training on department/division procedures, and policies.
    • Develop and implement procedures to comply with corporate and industry standards.
    • Understand and follow company procedures on regulatory requirements.
    • Provide support to the regulatory department in writing technical submissions.
    • Provide positive example and actively promotes compliance to all standards.
    • Maintain a professional working relationship with internal and external customer and support staff.
    • Prepare and present project updates and technical discussions.

    Basic Qualifications

    • Ability to make and present engineering decisions
    • Strong interpersonal skills
    • Demonstrated Project Management skills
    • Advanced statistics
    • Understanding and application of DOE
    • Ability to lead cross functional teams
    • Engineering cost analysis
    • Ability to analyze and optimize manufacturing and quality systems
    • Advanced product, design & prototyping skills
    • Ability to create and provide training
    • Software application skills
    • Advanced problem solving skills
    • Ability to create, review and coordinate test protocols and reports
    • Ability to generate engineering proposals
    • Oral and written presentation skills
    • In-depth knowledge of regulatory requirements
    • Ability to develop and control a budget
    • Ability to manage technical personnel
    • Ability to perform design review functions
    • Must read, write and understand English.  Must be detailed in handling information/data. 

    Additional Desirable Qualifications Skills and Knowledge

    Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.

    Education and/or Experience

    • A minimum of a Bachelors degree in a technical field.
    • Prefer a minimum of 6 years experience in the medical field or closely related industry or a Masters Degree plus three years.
    • Quality Engineering Certification (ASQ) or equivalent.
    • Extensive knowledge of FDA GMP/GLP, Medical Device Directive, ASTM, AAMI, CEN and ISO.

    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

    • BDPI 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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