Cantel Medical

  • Design Assurance Engineer

    Location US-MN-Plymouth
    Job ID
    2019-4874
    # 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.

    Job Overview

    The Design Assurance Engineer supports Cantel Medical’s New 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 validation, test plan and protocol development for Design Verification and Design Validation activities, data review and analysis from key testing activities, participating in Design 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.
    • Develop Test Plans and protocols independently and/or in partnership with R&D subject matter experts, conduct test execution and report generation.
    • Build design assurance plans for electrical, hardware and software – including Board level design, DSPs and FPGAs. Provide quality assurance & technical support for Track & Trace software and work closely with Technical services group for Pre-testing prior to deployment at Beta sites and the Field.
    • Familiarity with standards used in medical grade software development, and apply them for Design Assurance.
    • Responsible for the identification of technical standards against QSR, EPA, EU MDD/MDR 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 Design Quality Assurance 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/MDR, TGA, Health Canada and FDA quality systems, and participating in educational opportunities.

    Qualifications

    • BS degree in Electrical/Computer Engineering/Biomedical Engineering or Computer Science required. MS degree preferred.
    • 5 plus years of Design QA Engineering experience in a regulated medical device environment, specifically in a product development support role.
    • Prior experience in Embedded firmware design & testing.
    • Design and testing experience in electrical engineering and hardware – including Board level design, DSPs and FPGAs. Experience in responsibility for compliance to FDA, MDD/MDR and ISO regulations.
    • Experience in responsibility for medical device Design Verification and Validation activities of Electromechanical products.
    • Experience in and responsibility for product and process risk analysis/FMEA, specification writing, test method development and validation, 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
    • Previous work experience with IEC standards including but not limited to IEC 61010, IEC 60601, IEC 62304
    • Proficient in computer skills such as MS office programs

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