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Engineer I

1 month ago

Naples, United States Arthrex Full time
Essential Duties and Responsibilities:
  • Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
  • Manage and coordinate as assigned Product Improvement Projects including the design, engineering, quotation, documentation, manufacturability, and qualification of the project as required.
  • Participate in regularly scheduled complaint review meetings.
  • Provide timely corrective actions on all assigned defects and issues.
  • Build prototypes, products, and systems suitable for testing and may be required to set up and run lab simulations in order to perform root cause analysis.
  • Initiate and execute Engineering Change Orders (including model / drawing changes and / or new model and drawing creation) and Quality Plan updates.
  • Monitor corrective actions for effectiveness of implementation / solutions.
  • Recommends alterations to development and design to improve quality of products and/or procedures.
  • Determines budgets and timelines for assigned projects.
  • Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
  • Provides Regulatory department technical support for assigned projects as needed.
  • Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
  • Supports Manufacturing to provide processing improvements.
  • Determines necessity of testing and initiates testing of assigned products.
  • Reports progress and status of assigned projects on a timely basis to Engineering Manager.
  • Maintain familiarity with Company technology, organization, and business. Understand and provide technical solutions according to Arthrex strategy.

Education and Experience:

BS degree Engineering required. Mechanical, Biomedical, or Electrical Engineering preferred.

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

  • Working knowledge of anatomy from an orthopedic standpoint.
  • Working knowledge of manufacturing practices.
  • Knowledge of FDA and ISO guidelines for the development of medical devices required.
  • Project management and communication skills training preferred.

Machine, Tools, and/or Equipment Skills:

  • Proficiency in designing products using a 3D-CAD program. Creo and/or SolidWorks experience preferable.
  • Manufacturing process knowledge preferred.
  • Technical knowledge in development methodologies, design, and project implementation preferred.

Arthrex Benefits

  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)