C. R. Bard, Inc.

  • Sr. R&D Engineer

    Posted Date 2 months ago(5/30/2018 12:26 PM)
    Industry / Category
    Sr. R&D Engineer
    Job ID
    2018-11634
    Career Level
    experienced
    Division
    New Hope, MN / Lutonix
    Relocation
    Yes
    Location
    US-MN-New Hope
  • Summary of Position with General Responsibilities

    The Sr. R&D Engineer works cross-functionally to lead research and development efforts of complex technologies on drug eluting medical devices. The position focuses on drug coating development and processing including; project planning, innovative catheter and coating designs, prototype development, testing, characterization, analysis and reporting.

    Essential Job Functions

    • Research and develop drug coating formulations, coating processes and coating equipment.
    • Apply technical knowledge to innovate, design and develop processes, procedures, tooling and or automation.
    • Ensure process capabilities, prioritizing process improvement opportunities and implementing chosen improvements.
    • Execute New Product Development (NPD) deliverables working collaboratively with cross-functional team members.
    • Plan, organize and conduct all aspects of technical reviews for assigned projects.
    • Ensure proper documentation is complete and meets quality system requirements.
    • Write and review product development plans, design reviews, validation protocols and reports.
    • Oversee development builds associated with assigned projects.
    • Provide Design for Manufacturability (DFM) input for the engineering print package.
    • Contribute ideas and/or generate intellectual property submissions.

    Additional Desirable Qualifications Skills and Knowledge

    Preferred Qualifications:

    • Experience with balloon catheters, stents and stent delivery systems preferred
    • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.
    • Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment
    • Statistical analysis of data, pareto analysis, and other investigational tools
    • Demonstrated hands-on technical aptitude
    • Ability to travel to audit and/or transfer products to manufacturing partners
    • Excellent oral and written communication skills
    • Knowledge of cGMP and GLP
    • Knowledge of US FDA QSR and ISO 13485 requirements for design controls

    Education and/or Experience

    Education:    B.S. degree in Manufacturing Engineering, Mechanical Engineering or other related engineering discipline, or equivalent experience.

    Experience: Minimum 7 years of experience in R&D or process development, with a minimum of 5 years of medical device experience or another highly regulated FDA/QSR and ISO environment.

     

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

     

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