Systems Design Engineer

Spectranetics   •  

Orlando, FL

Industry: Healthcare

  •  

5 - 7 years

Posted 29 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 technical responsibility and project leadership for realization of new product releases and sustaining activities.

• Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements

• Systems design/architecture and Integration oversight.

• 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, 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:

  • Minimum of-BS Degree in Engineering- Electrical, Biomedical, Computer, Systems
  • Experience leading medical, or other regulated industry, product development
  • 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 quality-focused environment
  • Minimum 3+ years’ experience in a Systems Engineering role, or a role having overall systems responsibility focused in systems/embedded software, firmware, as well as-electrical (analog and digital) and mechanical.
  • 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
  • Knowledge performing risk management per ISO 14971

Preferred Requirements:

  • Understanding of US and international regulatory requirements for medical devices
  • Experience developing reliability plans
  • In depth knowledge in developing and testing products to IEC60601-1 Safety standard and IEC60601-1-2 EMC standard
  • Software development experience

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.

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