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Sr Device Risk Management Specialist in Naples, FL ,  at Arthrex

Date Posted: 1/26/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/26/2019

Job Description


Requisition ID:
41592
Title:
Sr Device Risk Management Specialist
Division:
Arthrex, Inc.
Location:
Naples, FL

Device Risk Management Specialist

We are looking for a strong, self-motivated medical device Risk Management Specialist to join and support the growth and development of our team.  We are looking for an experienced professional to continue our development and enhancement of efficient, best in class, systems supporting new product development in the application of risk management tools and practices.  You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to supporting continued business growth and expansion initiatives.  This is an opportunity to use your background and experience to leave a lasting mark on a fast-paced, growth-oriented, organization through the leadership and development of a newly formed group within our corporate team.  Candidates must be committed to excellence in all areas and take pride in providing elegant and scalable solutions to complex problems supporting Arthrex’s various business interests.

About You: 

  • •              Motivated, driven to learn, and thrive in a dynamic and fast paced environment;
  • •              Have a track record of continuous improvement of processes and programs to strive for efficiencies while maintaining high quality and compliant outputs;
  • •              Enjoy taking ownership of projects in a dynamic, team based atmosphere and modern work environment.

Some Details:

  • •              In-Depth understanding and application of risk management practices and approaches in design and manufacturing environments;
  • •              Hands-on experience in risk management program development, tool utilization, and risk mitigation;
  • •              Intimate working knowledge of relevant standards (i.e. ANSI/AAMI/ISO 14971, etc.);
  • •              Full understanding of state of the art / best practice and requirements governing the industry related to risk identification, assessment, control, and monitoring; 

About Us

Arthrex is a global medical device company and a leader in new product development, commercialization, and medical education in orthopaedics. As members of the Risk Management team, we are the front line in ensuring patient safety and supporting the organization in its mission of helping surgeons treat their patients better.   

Main Objective:

Responsible to manage specific aspects of the Arthrex risk management program with an emphasis on patient safety, and harm reduction. This position will play a critical role in the risk management efforts. In coordination with the Senior Manager of Pre-Production Quality, this role will design, coordinate and maintain various aspects of the patient safety and risk management programs for Arthrex.

Essential Duties and Responsibilities:

  1. Develop and promote the Arthrex Risk Management processes for medical devices, including managing and maintaining global policies and procedures;
  2. Create, manage, and maintain device risk management files and associated documentation in accordance with the requirements of ISO 14971 and global regulatory requirements part of the device design process;
  3. Facilitate and lead Product Safety review board activities, ensuring recordable events are appropriately documented, communicated, and dispositioned, with outputs implemented back into design and/or quality management system procedures & processes;
  4. Generate health hazard evaluations (HHE) to appropriately document and disposition patient and/or user health hazards arising from product complaints or non-conformances;
  5. Partner with Design Engineering and Program Management to ensure appropriateness and adequacy of quality management system documentation facilitating design and development planning and execution;
  6. Function as the global representative for Arthrex Risk Management process during Agency/3rd Party Audits and assists in the preparation and submission of audit responses and requests for information to FDA, Notified Body and other Regulatory Bodies;
  7. Collect and analyze product design and quality data to facilitate generation of lessons learned, improvement of processes, and assurance of patient safety;
  8. Participate in program design reviews and ensure risk traceability to design requirements and risk mitigations are clearly documented and maintained;
  9. Provide guidance and support to design and manufacturing teams in the generation of risk source documentation, e.g., dFMEA, pFMEA, Fault Tree Analysis, etc.
  10. Support the development of test plans, design documentation reviews, and risk mitigation execution.

    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/Latitude

    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.
  • Manufacturing process knowledge preferred.
  • Project management and communication skills training preferred.
  • Working knowledge of risk management requirements.
  • Working knowledge of device clinical use and associated harms and hazards
  • Knowledge of orthopedic surgery principles, theories, and products preferred.
  • Historical perspective on risk management programs and requirements preferred.

Personnel supervision experience preferred

Education & Experience

Bachelor’s Degree in Engineering or Science Related study, or related areas required.

seven years’ experience in an FDA /ISO regulated environment.

Previous project leadership experience required.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

Experience in project management, risk management (such as FMEA, FTA, FMECA) tools are highly desirable.  Experience in working with Medical Device Risk Management (Specifically ISO 14971), CAPA, Complaint Management, and Nonconformance Reporting required. 

Machine, Tools, and/or Equipment Skills:

Proficiency in the use of Personal Computers and computer programs, particularly the Microsoft Office Suite; Excel, Word, PowerPoint (or equivalents if changed by the Company).  SAP and / or Pilgrim Quality Data experience desirable.

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.