Systems Design Engineer, EU

Philips Electronics   •  

Orlando, FL

Industry: Healthcare

  •  

5 - 7 years

Posted 36 days ago

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

In return, we offer you:-

An opportunity to sharpen your talents with new challenges in our dynamic organization. As a market-driven company, we’re used to listening to our customers & apply the same thinking to our employees. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.

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