C. R. Bard, Inc.

  • Senior Product Development Engineer (PDE)

    Posted Date 2 months ago(2/14/2018 9:42 AM)
    Industry / Category
    Medical Device / Product Development
    Job ID
    Career Level
    BD Interventional / Surgery
  • 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.

    The Surgery business unit is situated in a central location, surrounded by a scenic coastline with easy access to T.F. Green Airport, AMTRAK Train Stations and Route 95, a major highway connecting to Providence, Connecticut, Boston and New York City within a short amount of time.

    Summary of Position with General Responsibilities

    This position is responsible for coordinating and implementing the development and commercialization activities associated with making improvements to existing medical device products and/or processes used to manufacture medical device products. In addition, the Senior PDE has an emphasis on leading and managing technical aspects of programs in a matrix organization through influence at all levels of the organization.

    Essential Job Functions

    • Plans, coordinates and manages development and manufacturing activities related to maintenance of legacy products including:
      • Concept and development of methods and processes.
      • Coordination of new tooling and equipment.
      • Coordination and support of new vendor tooling.
      • Development and release of product and process documentation.
      • Support the plant with qualification and validation of new operations and processes including review of DOEs, validation protocols, data analysis and reports.
      • Support the plant with capital expense requests.
      • Evaluation and recommendation of new materials.
    • Works with Finance team representatives to determine proposed value of projects.
    • Supports team to determine project objectives and assures programs meet all objectives.
    • Works directly with concept development lab and/or outside shops for fabrication of prototype molds, tooling and/or prototype components and assemblies.
    • Works with in-house personnel or outside shops in assembly of prototype components for testing.
    • Generates Risk Assessments for the impact of proposed changes on existing processes.
    • Works concurrently with Manufacturing Engineering, Quality Engineering and Regulatory Affairs groups in documenting product / process improvements or changes.
    • Schedules and conducts Product and/or Process Design Review meetings.
    • Makes recommendations and/or assists Manufacturing Engineering groups in selecting equipment and/or developing processes for manufacturing new or improving existing products.
    • Review and analyze costs and waste to identify cost improvement opportunities.
    • Supports Maintenance of Business activities as needed by the Davol Franchise teams.
    • Special projects as assigned.

    Basic Qualifications

    • Bachelor’s degree in Mechanical, Chemical, or Biomedical Engineering required.
    • With Bachelors, minimum of five years relevant product development experience in the surgical, disposable medical products or related industries. With Masters, minimum of four years relevant product development experience in the surgical, disposable medical products or related industries. Proficiency with mold tooling and design, machinery, assembly fixtures, equipment and tooling procurement and design.
    • Strong background and knowledge in electro-mechanical design and assembly.
    • Strong background and knowledge in Medical Device Design Control.
    • Must be able to handle a variety of projects at the same time.
    • Skilled in experimental design, process validations and test method validations.
    • Excellent verbal and written communication with all levels of technical and operating management.
    • Broad knowledge and use of medical devices.
    • Knowledge of GMPs and current FDA medical device regulations.
    • Ability to conceptualize ideas, motivate and focus individuals and teams and drive projects through completion on time and on budget.
    • Ability to travel occasionally (up to 25%)

    Additional Desirable Qualifications Skills and Knowledge

    • Masters in Chemical, Mechanical, or Biomedical Engineering.

    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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