System Engineer- Medical Device Orlando, Florida

System Engineer- Medical Device

Full Time • Orlando, Florida
Job Title: System Engineer
Location: Orlando, FL (Onsite)

Job Description:

·         Systems Engineering in the medical area is what is needed and experience with these specs:
·         In depth knowledge performing risk management per ISO 14971
·         In depth knowledge in developing and testing products to IEC60601-1 Safety standard
·         In depth knowledge in developing and testing products to IEC62336 EMC standard

These are the next things to look for:

·         Experience with deriving and simulating human interactions with devices and device use conditions
·         Experience with electronic requirement data management SW – preferably DOORS
·         Minimum five years engineering / R&D experience in a rigorous quality-focused environment
·         DOORS and experience writing, reviewing requirements.

In this role, you have the opportunity to:

·         Be a key contributor in the design and development of the Philips Clinical Applications and Devices Organization which includes MR Patient care a market leader in MR patient monitors which are the chosen solutions for the top 10 children’s hospitals in the U.S.

You are responsible for:

·         Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
·         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 Clinical Applications and Devices Organization 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
·         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
·         Experience with electronic requirement data management SW – preferably DOORS
·         Minimum five years engineering / R&D experience in a rigorous quality-focused environment
·         Minimum three 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
·         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
·         In depth knowledge in developing and testing products to IEC60601-1 Safety standard
·         In depth knowledge in developing and testing products to IEC62336 EMC standard

 Preferred Requirements:

·         Understanding of US and international regulatory requirements for medical devices strongly preferred
·         Experience developing reliability plans
·         Knowledge of product development processes and best practices
·         Knowledge of verification and validation testing processes
·         Electrical or Software development experience is a plus
·         Master’s degree preferred

Compensation: $50.00 - $60.00 per hour




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