Systems Design Engineer, EU/MDR

Phillips   •  

Orlando, FL

Industry: Healthcare


5 - 7 years

Posted 79 days ago

This job is no longer available.

Job Title

Systems Design Engineer, EU/MDR

Job Description

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