Engineer - Quality (Medical Device)

2 weeks ago

naples, United States Arthrex Full time
p>Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better™. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.
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 Lunch
Tuition Reimbursement Program
Trip of a Lifetime
Paid Parental Leave
Paid Time Off
Volunteer PTO
Employee Assistance Provider (EAP)
Please note, most benefits are for regular, full time employees.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.

Arthrex, Inc. is a global medical device company leader in new product development and medical education in orthopedics. We are actively searching for an experienced Senior Engineer in medical device product development for the Trauma team. This engineer will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Excellent communication and interpersonal skills, five plus years of medical device design and development experience and a bachelor’s degree in Engineering are essential for this position. Experience in CAD software is also required. Project management experience strongly preferred. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

  • Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
  • Recommends alterations to development and design to improve quality of products and/or procedures.
  • Determines budgets and timelines for assigned projects.
  • Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget. 
  • 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.
  • Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
  • Determines necessity of testing and initiates testing of assigned products
  • Reports progress and status of assigned projects on a timely basis. 
  • May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Education/ Experience:

  • 5 years of relevant experience required
  • Bachelor’s degree in engineering required, preferably in Mechanical, Biomedical, or Electrical Engineering

Skills:

  • Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
  • Project management and communication skills training preferred.
  • Proficiency in designing products using a 3D-CAD program.  Creo and/or SolidWorks experience preferable.
  • Technical knowledge in development methodologies, design, and project implementation.

Knowledge:

Complete understanding and application of principles, concepts, practices, and standards.  May refer to established precedents and policies.

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