Responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.
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.
Support team efforts in establishing project design inputs and/or requirements, ensuring compliance to Arthrex QMS, Global Standards and Regulatory Requirements
Manage completion of Design Control Documentation, such as: Traceability Matrix’; Risk Management File; FMEAs; Verification and Validation Test Protocols and Reports; etc.
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.
Complete understanding and application of principles, concepts, practices, and standards. Full knowledge of industry practices.
Develops 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.
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. 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 principals, theories, and products preferred.
7 Years of experience. BS Degree Engineering. Mechanical, Biomedical, Electrical or Software Engineering preferred. MS Preferred
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.