Principal Engineer - Product Development - I&R (Remote)
ArthrexAbout 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 Principal Engineer – Product Development to support our Imaging & Resection team. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.
This is a fully remote position.
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.
- 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.
Knowledge:
- Regularly contributes to the development of new concepts, techniques, and standards.
- Considered expert in field within the organization.
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.
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.
Education/Experience:
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