This site uses cookies. To find out more, see our Cookies Policy

Sterilization Sciences and Biological Safety Sr Project Manager in Naples, FL ,  at Arthrex

Date Posted: 2/1/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    2/1/2019

Job Description


Requisition ID:
42035 
Title:
Sterilization Sciences and Biological Safety Sr Project Manager
Division:
Arthrex, Inc.  
Location:
Naples, FL

Main Objective:

Responsible to manage the testing aspects of the Arthrex Sterilization and Biocompatibility programs with emphasis on cost reduction and increase in testing efficiency. This position will play a critical role in centralizing all microbiological, chemical, and biocompatibility testing.  In coordination with the Manager of Sterilization Sciences & Biological Safety, this role will coordinate required tests associated to new product development and routine maintenance, compile data, and maintain various systems and laboratory relationships, while monitoring expenditure and yearly budgets for Arthrex.

Essential Duties and Responsibilities:

  1. Develop and promote laboratory testing strategies for the Sterilization Sciences and Biological Safety department to support Arthrex new product development and routine testing to ensure and maintain compliance;
  2. Identify and qualify testing facilities in an effort to select vendors that best support Arthrex test demands and programs.
  3. Coordinate all departmental microbiological, chemical, and in-vitro/in-vivo testing, from proper submission documents to suitable sample identification and on-time shipment and delivery, to ensure that testing timelines are met;
  4. Collaborate directly with Sterilization and Biocompatibility specialists to meet and support project needs and timelines by ensuring that critical dates are fulfilled.
  5. Manage and maintain global routine monitoring testing activities to guarantee on-going compliance of existing products.  Communicate with manufacturing and testing vendors to ensure timely delivery of test samples and test completion.
  6. Review and maintain all testing results using specific tools and systems adopted by the department for easy access and retrieval of data;
  7. Generate and the manage purchase orders for all testing vendors to guarantee remittance to invoices with the scope of maintaining active service status with vendors;
  8. Maintain financial reports using specific metrics on established intervals to monitor the testing expenditure in relationship to the assigned budget and the need of strategy implementation.
  9. Investigate and manage all laboratories quality events, and assess resolutions with the scope to reduce occurrences;
  10. Function as the global Arthrex representative for all correspondences to testing laboratories in order to centralize all communications.

Knowledge: Complete understanding and application of principles, concepts, practices, and standards.  Full knowledge of industry practices.

Reasoning Ability: Develops solutions to a variety of complex problems.  May refer to established precedents and policies.

Discretion/Latutude: Work is performed under general direction.  Participates in determining objectives of assignment.  Plans schedules and arranges own activities in accomplishing objectives.  Work is reviewed upon completion for adequacy in meeting objectives.

Skills:

  • Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
  • Intimate Knowledge of ISO/AAMI sterilization and Biocompatibility guidelines.
  • Project management and communication skills training preferred.
  • Intimate Knowledge of ISO 17025 guidelines.
  • Working knowledge of testing environments and testing methodologies governing the medical devices industry
  •  Working Knowledge of the orthopedic sector of the medical device industry is preferred.
  • Proven track record of laboratory testing efficiency gains
  • Working Knowledge of fundamentals of finance principles

Education & Experience:BS Degree in Microbiology or related field, or 10 years relevant experience required. At least 7 years relevant experience in laboratory testing or medical device industries.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.