C. R. Bard, Inc.

  • Sr. Manufacturing Engineer

    Posted Date 6 months ago(1/23/2018 9:45 AM)
    Industry / Category
    Sr. Manufacturing Engineer
    Job ID
    2018-11074
    Career Level
    experienced
    Division
    Woburn, Massachusetts
    Relocation
    Yes
    Location
    US-MA-Woburn
  • Overview

    BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties. 

    Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company. 

    BDI Surgery's Woburn, Massachusetts manufacturing facility manufactures hemostasis products, hernia and abdominal wall repair products. The facility also manufactures biological odor eliminators and creams/gels for BDI Interventional's Urology & Critical Care business unit, which is used primarily in hospitals and nursing homes. 

    Summary of Position with General Responsibilities

    The Sr. Manufacturing Engineer functions as the technical lead and provides engineering support and direction throughout the manufacturing facility in areas such as process improvements, technological advancements, transfer of new projects on loads, existing manufacturing product line support, cost improvements, facility maintenance, safety and environmental regulation.

    Essential Job Functions

    • Support existing manufacturing product line(s).
    • Lead and participate in plant CIP and process improvement programs as required.
    • Support activities such as failure investigation, design of experiments, process capability studies, qualifications and validations (IQ,OQ,PQ’s) of processes and/or equipment.
    • Coordinate tactical plans geared towards timely completion of line extensions and major equipment installations, modifications or enhancements.
    • Participate in safety and environmental programs as required.
    • Initiate and execute cost improvement projects.
    • Lead and/or participate in facility improvement activities.
    • Select and qualify vendors for the procurement of production equipment or production materials.
    • Develop process engineering controls and specifications for manufacturing processes and associated equipment.
    • Act as a Key team member in assisting the transfer of new product on-loads and product off-loads from R&D to Manufacturing.
    • Author document changes in accordance with regulatory and corporate requirements.
    • Train and mentor employees on product specifications and procedures.
    • Performs other duties as required and requested in support of plant goals.

     

     

    Basic Qualifications

    • Bachelor’s of Science degree in Engineering required.
    • With Bachelors, minimum of five years in manufacturing technical operations. With Masters, minimum of four years in manufacturing technical operations.
    • Extensive knowledge of GMP and FDA regulatory requirements for drugs and / or devices
    • Strong verbal and written communication skills
    • Experience generating and releasing quality controlled documents such as IQ/OQ/PQ, test method validations, and component qualifications
    • Reliable self-starter who collaborates and leads fellow team members to accomplish tasks and meet deadlines.
    • Experience in leading and coordinating technical staff desirable
    • Experience in safety and environmental programs desirable
    • Experience training personnel on manufacturing procedures

    Additional Desirable Qualifications Skills and Knowledge

    • Master’s degree in engineering or business
    • Experience working with PMA and/or class III medical devices
    • Six Sigma or equivalent certification with real world application to product or processes
    • Experience working with filling equipment, preferably with powder based products
    • Knowledge of collagen processing and chemical compounding and fillings is desirable

    Education and/or Experience

    BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.

     

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