System Engineer- IEC 60601

3 weeks ago


Orlando, United States DBSI Services Full time
Job DescriptionJob DescriptionBenefits:
  • 401(k)
  • 401(k) matching
  • Relocation bonus

Job Title System Engineer

Location Orlando, FL
Job Description:
Responsibilities:

Overall technical leadership and responsibility for the 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 IEC 60601-1 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

Masters degree preferred



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