Validation Engineer III
Alphatec Spine
Principal Engineer - Product Development - I&R
Artex Risk Solutions
full-time
Posted on:
Origin: • 🇺🇸 United States • Florida
Visit company websiteSalary
💰 $152,501 - $253,575 per year
Job Level
Lead
About the role
- Responsible for full life cycle development of medical devices: initiation, design, development, execution, and product maintenance
- Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing
- Recommend alterations to development and design to improve quality of products and/or procedures
- Determine budgets and timelines for assigned projects and report progress/status in a timely basis
- Lead multifunctional new product project teams through technical feasibility analysis, initiation, planning, execution, and termination
- Maintain design history file for assigned projects adhering to Arthrex design control procedures
- Provide Regulatory department technical support and support Marketing/Product Management with technical information
- Support Manufacturing for processing improvements and support surgeon and distributor customers via training/education
- Determine necessity of testing and initiate testing of assigned products
- May be required to travel to trade shows, visit accounts, and international travel may be required
Requirements
- Bachelors degree in Engineering required
- 12 Years of relevant work experience (144 months)
- Knowledgeable of FDA and ISO guidelines for the development of medical devices
- Proficiency in designing products using a 3D-CAD program
- Technical knowledge in development methodologies, design, and project implementation
- 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
- State of the art knowledge of orthopedic surgery principles, theories, and products preferred
- Ability to travel domestically and internationally as required
- Ability to supervise lower level personnel (may supervise)
- Ability to verbally communicate ideas and issues effectively and write required documentation
