Arthrex, Inc. is seeking a Principal Engineer – Product Development to support their Imaging & Resection team, responsible for the full life cycle development of medical devices.
Requirements
- Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
- Proficiency in designing products using a 3D-CAD program.
- Technical knowledge in development methodologies, design, and project implementation.
- Manufacturing process knowledge preferred.
- Working knowledge of anatomy from an orthopedic standpoint preferred.
- Working knowledge of joint anatomy preferred.
- State of the art knowledge of 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.
- 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.
Other
- This is a fully remote position.
- Determines budgets and timelines for assigned projects.
- May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.
- Project management and communication skills training preferred.
- 12 Years of relevant work experience.
