Systems Design Engineer, EU/MDR
In this role, you have the opportunity to:
Be a key contributor in the design and development of Philips- Invivo's , market leading, MRI Systems and products, which are the chosen solutions for the top 10 children’s hospitals in the U.S.
You are responsible for:
• Overall R&D technical lead for regulatory projects, primarily the European Union Medical Device Regulatory (EU/MDR) program.
• Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
• Support for NPI efforts that create value for Philips-Invivo through- innovation and design, while delivering high quality engineering solutions.
• Technical liaison to the program
• Defect/Risk management and Design Reviews
You are a part of:
A team of highly skilled engineers that is focused on creating world-class health care solutions. Our focus on improving lives contributes to our amazing work environment and culture.
To succeed in this role, you should have the following skills and experience:
- BS Degree in Engineering- EE, Biomedical, Systems or comparable disciplines
- Experience advising medical product development in EU/MDR compliance
- Experience in leading groups to solutions for complex problems
- Experience with deriving and simulating human interactions with devices and device use conditions
- Minimum 5+ years engineering / R&D experience in a rigorous FDA quality-focused environment
- Minimum 3+ years’ experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
- Excellent requirements and specification writing skills
- Knowledge of product development processes and best practices
- Knowledge of verification and validation testing processes
- Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
- Ability to build and maintain effective cross-functional and cross-organizational relationships
- Excellent oral, written and presentation skills
- In depth knowledge performing risk management per ISO 14971
- Understanding of US and international regulatory requirements for medical devices