Principal Engineer - Product Development - I&R

Requisition ID: 58556 Title: Principal Engineer - Product Development - I&R Division: Arthrex, Inc. (US01) Location: Naples, FL

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Principal Engineer - Product Development for I&R will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. We are looking for an innovative, experienced Engineer with a bachelor's degree in Engineering, an experienced CAD user and knowledgeable in medical device industry regulations. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• 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:

• 12 years of relevant experience
• BS Engineering; Mechanical, Biomedical, Electrical Engineering preferred
• MS Preferred

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 anatomy from an orthopedic standpoint preferred.
• Working knowledge of joint anatomy preferred.
• Proficiency in designing products using a 3D-CAD program.
• Technical knowledge in development methodologies, design, and project implementation.
• State of the art knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on orthopedic surgery principals, theories, and products preferred.

Knowledge:

Regularly contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.

Reasoning Ability:

Develops solutions to complex problems, which require the regular use of ingenuity and innovation. Ensures solutions are consistent with organization objectives.

Discretion/ Latitude:

Work is performed without appreciable direction. Exercises considerable latitude in determining objectives and approaches to assignment. May supervise the activities of lower-level personnel.

Arthrex 2023 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)

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.