Cantel Medical

  • Engineer, Design Assurance

    Location US-MN-Plymouth
    Job ID
    2019-5204
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Medical
  • Company Overview

    At Cantel, preventing infection is our business. We are dedicated to delivering high-quality, innovative solutions that help our customers improve patient care. Choosing a career with Cantel means joining a company that’s driven by an entrepreneurial spirit and the passion to shape the future of infection prevention. If you want to be inspired by your work and have a hand in shaping the future of infection prevention, we want to meet you. Come and see why people love working here.
    Cantel is a leading global company dedicated to delivering innovative infection prevention products and services for patients, caregivers, and other healthcare providers which improve outcomes, enhance safety and help save lives. Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products. Additionally, we provide technical service for our products. Cantel medical is a leading provider of infection prevention products and services in the healthcare market, specializing in the following operating units:
    Medical
    Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. This segment is operated through MEDIVATORS.
    Life Sciences
    Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc. and MEDIVATORS.
    Dental
    Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc.

    #CB

    Job Overview

    The Design Quality Assurance Engineer supports Cantel Medical’s Product Development and
    Sustaining Engineering teams and plays a key role in Cantel’s Product Development and Design
    Control processes. Product Design QA Engineers are responsible for engineering activities
    including review and gap assessment of design requirements, development, execution and
    maintenance of risk management plans and activities, identification of applicable standards,
    review of component and system level specifications, test method development, test plan and
    protocol development for Design Verification and Design Validation activities, data review and
    analysis from key testing activities, participating in Design Stage Reviews and process validation
    activities related to Design Transfer to Manufacturing.

    Main Responsibilities

    Work with Cantel Medical Product Development team to execute risk based
    approach/procedure/plan to develop/design requirements/specifications, technical
    standards, test methods, test plans, test protocols and test data analysis.
     Responsible for the identification of technical standards against QSR, EPA, EU MDD and other
    target market regulatory and clinical requirements.
     Responsible for partnering with Product Development teams and Supply Chain personnel in
    the assessment of component and system level specifications relative to customer needs and
    product performance specifications.
     Apply Design for Reliability and Manufacturability tools and techniques to ensure Cantel
    product designs are robust, fit Cantel’s manufacturability model, and meet customer needs.
     Provide effective Quality Engineering support for multiple projects, balancing priorities and
    resources appropriately to meet both project and management expectations.
     Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain and Manufacturing to
    ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ as
    applicable for products and processes in the concept to market phases of product
    development.
     Assist in continuous improvement activities as necessary and as driven by product lifecycle
    management that generate Sustaining Engineering projects.
     Prepare oral and/or written reports of analysis for Design Verification, Design Validation and
    other critical testing and evaluation activities, as required by the project or department
    management.
     Update job knowledge by keeping abreast of trends and developments in design quality
    assurance, statistical analysis, test development, ISO 13485, MDD, TGA, Health Canada and
    FDA quality systems, and participating in educational opportunities.

    Qualifications

     BS degree required, Diploma holder in Engineering or Physics
     3 plus years Design Quality Assurance experience in a regulated medical device
    environment, specifically in a product development support role
     Experience in responsibility for compliance to FDA, MDD and ISO regulations
     Experience in responsibility for medical device Design Verification and Validation activities
     Experience in and responsibility for product and process risk analysis/FMEA, specification
    writing, test method development, statistical analysis of quantitative and qualitative data,
    test report writing and medical device design reviews.
     Previous work experience in life science products or medical device fields is required
     Proficient in computer skills such as MS office programs
    IDEAL CANDIDATE PROFILE:
    Personal Characteristics:
     Strong written and oral skills
     Strong organizational and management skills
     Strong problem solving skills
     Strong attention to detail

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