Sr. Engineer I - Product Development - Arthroplasty

About the role

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 Sr. Engineer I – Product Development to support various projects within Arthroplasty.

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.

Requirements

• Complete understanding and application of principles, concepts, practices, and standards.
• Full knowledge of industry practices.
• Knowledgeable of FDA and ISO guidelines for the development of medical devices 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. Creo 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.
• QMS experience preferred.

Qualifications

• 5 years of relevant work experience excluding academic coursework or internships required.
• Bachelor’s degree in Engineering required.
• Arthroplasty experience preferred.