Engineer Sr I, Patient Specific Devices

Arthrex•Pelican Bay, FL

About The Position

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

Requirements

Bachelors degree in Engineering (Mechanical, Biomedical, Electrical or Software Engineering) is required
Minimum of 5 years of related experience
Working experience in designing products using a 3D-CAD software such as Solidworks, Materialise 3-matic, Mimics and/or Pro/E
Knowledgeable of FDA and ISO guidelines for the development of medical devices required.

Nice To Haves

Manufacturing process knowledge preferred.
Project management and communication skills training preferred.
Working knowledge of anatomy from an orthopedic standpoint and joint anatomy preferred.
Full understanding of surgical planning and design process with the ability to properly train others.
Technical knowledge in development methodologies, design, and project implementation.
Knowledge and historical perspective of orthopedic surgery principles, theories, and products, preferred.

Responsibilities

Support all patient-matched implants and instrument design and surgical planning activities.
Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
Serve as internal and customer facing technical lead.
Foster new and return customer relationships through technical presentations and on-site visits.
Provide surgical planning feedback for other team members internally within the group.
Recommends alterations to development and design to improve quality of products and/or procedures.
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 support surgical cases up to 15% and occasional off hours surgical support.