6 days old
2018-08-082018-09-05

Systems Engineer

Monroeville, PA 15146
  • Job Code
    637969
  • Payrate
    $55 To $60
job summary:

Awesome Opportunity for Systems Engineer on a Dynamic Medical Device team in Monroeville!

Successfully help lead cross-functional teams of mechanical, electrical, and software engineers in the development, verification, and validation of new and existing technologies to create innovative and reliable new product designs for the Respiratory Care ventilation product line with an emphasis on Systems Engineering.

 
location: Monroeville, Pennsylvania
job type: Contract
salary: $55 - 60 per hour
work hours: 8 to 5
education: Bachelors
 
responsibilities:
  • Work closely with Marketing in understanding clinical needs, market observation for new products, trends, and competition developments and document product requirements from these needs.
  • Be responsible for the generation of product requirements documents and contribute to the overall system architecture of new products.
  • Be responsible for the product Usability File including writing and executing Human Factors and Usability Protocols.
  • Be responsible for overall product Verification and Validation test requirements including all medical device ISO safety and compliance standards.

The successful candidate will demonstrate:

Leadership - The ability to make things happen by encouraging and channeling the contributions of others, taking a stand and addressing important issues, and acting as a catalyst for change and continual improvement.

Innovation & Change - While ensuring quality, look for ways to enhance effectiveness and efficiency of the organization's systems, processes and tools. Be flexible to change what is not working well.

Job skills & Knowledge - Full knowledge and understanding of the work responsibilities. Successful application of knowledge and skills to produce quality work. Continue to add new knowledge for personal and organizational growth. Proactively share knowledge with others.

Teamwork - A positive team-member, who listens to other opinions, accepts and uses suggestions for improvement and contributes to the overall team effort. Ability to flex assignments in order to meet group objectives and milestones.

 
qualifications:

Education Requirements:

Bachelor of Science in an Engineering Discipline preferred.

Behaviors:

Must be able to thrive in a fast paced, team oriented, new product development environment.

 
skills: Position Requirements:

  • Demonstrated experience with creating new concepts, demonstrating feasibility, completing development, documentation, validation, and release of new products.
  • Demonstrated experience with soliciting and generating Product Requirements.
  • Minimum of 5 to 10 years of related experience.
  • Direct experience with European Union Medical Device Regulation, preferred.
  • Direct experience with ISO Safety Standards for Medical Devices, preferred.
  • Direct experience with FDA Requirements (including safety and regulatory testing) and their application within a medical product development environment, preferred.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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Systems Engineer

Randstad Technologies
Monroeville, PA 15146

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Randstad Technologies
Monroeville, PA
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