Engineer Principal - Electrical - Product Development - Medical Devices

Arthrex

About The Position

The Engineer Principal - Product Development will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.

Requirements

12 Years of experience
Bachelor’s degree (or equivalent experience) required preferably in Engineering (Mechanical, Biomedical, Electrical or Software Engineering) or Computer Science
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Regularly contributes to the development of new concepts, techniques, and standards. Considered expert in field within the organization.
Develop solutions to a variety of complex problems. May refer to established precedents and policies.
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.

Nice To Haves

MS Preferred
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. Pro/E and/or SolidWorks experience preferable.
Technical knowledge in development methodologies, design, and project implementation.
Knowledge of orthopedic surgery principles, theories, and products preferred.
Historical perspective on orthopedic surgery principles, theories, and products preferred.

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 a history design file for assigned projects, adhering to Arthrex design control procedures.
Provides Regulatory department with 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 them on technical aspects of assigned products as needed.
Determines necessity of testing and initiates testing of assigned products
Reports on 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.