Principal Product Development Engineer

Main Objective: Responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.

Essential Duties and Responsibilities:

1. Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
2. Recommends alterations to development and design to improve quality of products and/or procedures.
3. Determines budgets and timelines for assigned projects.
4. 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. 
5. Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
6. Provides Regulatory department technical support for assigned projects as needed.
7. Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
8. Supports Manufacturing to provide processing improvements.
9. Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
10. Determines necessity of testing and initiates testing of assigned products
11. Reports progress and status of assigned projects on a timely basis. 
12. May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Education/ Experience

• 15 Years of experience
• BS Degree Engineering.  Mechanical, Biomedical, Electrical or Software 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.

Incidental Duties:

The above statements describe the general nature and level of work being performed in this job.  They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

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.