Cantel Medical

  • R&D Program Manager MDR EU

    Location IT-Pomezia
    Job ID
    2019-5234
    # Positions
    1
    Category
    Quality / Regulatory
    Company
    Cantel Italy
  • 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 Program Manager manages cross-functional teams to accomplish the tasks necessary to assure that the overall program goals are delivered on-time, within budget, and all performance requirements are met. This position manages the development and/or enhancement of products and systems of products utilizing the design control process that is part of the Cantel quality system. Strong leadership, organizational and communication skills are critical as well as ability to perform in a constantly fluctuating and fast paced environment.
    As related to completing projects needed to ensure compliance to the EU MDR requirements, the Program Manager must be able to work with Marketing, Sales, Finance, Regulatory, R&D, Operations and Upper Management to clarify and refine requirements, set and manage budgets and prioritize activities. This person should have experience working with resources external to Cantel such as contractors and non-Cantel partner organizations to complete the project deliverables. This person should have a good understanding of how each program benefits both the company and the customer. This person must be able to effectively lead large and company critical programs comprising multiple projects and involving up to 40 team members that may reside in different locations around the world.

    Main Responsibilities

    • Define and recommend a program team and gain approval from management for team member support.
    • Create an environment where team members feel free to speak and know that their concerns will be addressed.
    • Able to gain consensus and agreement (buy-in) from the team and management to support decisions.
    • Make decisions and adjustments to program/project direction, schedule, and resource allocation based upon data and facts obtained from the program team.
    • Possess or develop an intimate understanding of the requirements needed to achieve compliance to EU MDR regulations.
    • Provide positive feedback to team members for a job well done, and offers suggestions to improve when appropriate.
    • Understand and follow the new product development design control system.
    • Define and develop a program/project plan, schedule, resource requirements, hazard analysis, cost estimates, and other required documents with the core team.
    • Work with cross functional team to establish comprehensive design inputs and requirements sets. Work with marketing to establish required voice of customer evidence.
    • Manage the program’s progress towards established goals and identifies and communicates risks that may affect the expected outcome.
    • Assure that the product requirements have been met through testing and analysis.
    • Resolve problems that arise during development.
    • Track expenses and product cost and performance against scheduled milestones.
    • Resolve resources issues and program conflicts between team members and the organization.
    • Participate in completion of the program/project tasks as needed.
    • Domestic and international travel may be required up to 20% of work time.
    • Other duties as assigned by the supervisor, which may include ownership of existing/new business or NPD governance processes or related organizational improvement initiatives.

     

     

    Qualifications

    • Bachelor’s Degree in a Science or Engineering field
    • Minimum of 10 years related medical device or Pharma R&D experience and/or training of which includes 5 years’ experience in a Project/Program Leadership capacity required
    • Project Manager (PMP) certification is highly preferred or equivalent
    • Demonstrated ability to work with contract staff and contract development houses a plus.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to objectively analyze data provided by team members to assure that conclusions are valid.
    • Ability to visualize an overall picture of the program/project tasks and their interrelationships in order to identify potential conflicts or problems.
    • Demonstrated ability to read, analyze, and interpret common scientific and technical reports,
    • Demonstrated ability to communicate complex information clearly in verbal and written form, effectively present information to senior staff (Phase reviews, updates) and represent the company during on and off site meetings with entities outside the company.
    • Availability to travel up to 30% of the time
    • Fluent English and Italian capability
    • Must be very customer (internal and external) focused and results driven.

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