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Job Information
Job title

Systems Engineer

Company Cybercoders.com
Wage between $0.00 - $0.00 Annually
Location United States, Minnesota, Minneapolis
Employment type Full Time
Education Not Specified
Year Experience 4 - 5 Years of Practical Experience
Travel Not Specified
Published on 5/26/2009
Description
Systems Engineer Systems Engineer 

Skills Required 
Systems Engineer, Medical Device,senior Level Design, Testing,Complex Systems, DHR & DMR,Web Application, JAVA or .NET,Compliance,FDA & ISO,IEC & UL Regulations

System Engineer - Software Development

System Engineer will work across engineering functional teams to develop a remote patient monitoring system for implanted cardiac devices. The remote patient monitoring system (for home use) will support the remote collection of patient data and the analysis and reporting of the data through an information management system providing Web access to health care professionals.

The System Engineer will support the product from conception through commercialization by engaging in all phases of product development including building Web applications for remote usage.

The System Engineer will have responsibility for the technical content of system development including definition, design, integration and verification.

What you will be doing:
Work cross functionally (marketing, clinical, service, manufacturing, regulatory and quality organizations) to identify and document product requirements. Will maintain traceability between system requirements, design and testing.
Work within engineering to translate product requirements into design specifications that acknowledge technical, schedule, and cost constraints.
Lead the creation of the system architecture to ensure reliable system function, writing system specifications and design descriptions, define critical interfaces between sub-systems, and managing sub-system interactions to ensure proper system function. This work will include system hazards analysis and adjusting the system design to mitigate hazards
Publishes baseline specifications, conducts cross-functional reviews, and incorporates issues to produce a coherent system specification. Ensure correctness and adequacy of the system documentation, be responsible for obtaining approval of system documents and managing the DHF and DMR.
Conduct performance evaluation studies, technology assessment activities, and analyze system integration issues for the system. Ensure that concept studies and feasibility work have adequately addressed and resolved issues that would affect product development to proceed with minimal technical and schedule risk.
Plan and execute system verification and validation activities to ensure compliance with FDA regulations, ISO regulations and company standard operating procedures.
Exercises judgment in planning and organizing role responsibilities and works with the PM to define system development, integrations and testing activities. Monitors performance and reports status to program management. Uses best business practices to ensure success in areas of responsibility.
Complies with FDA and ISO regulations for Class III medical devices and with our new product development policies, practices and procedures. Must be adept in working in a highly regulated environment (life sustaining medical devices).
Stays current with advances in technology and the medical device industry including policies, standards and strategies. Uses this information to assist system manager with the identification of future needs and strategic planning.
Possible relocation assistance for an ideal candidate!

An ideal candidate must have:
Bachelor's Degree in Computer Science, Electrical Engineering, a related field, or equivalent is required. An advanced degree preferred.
5 years as a System/Software Engineer defining complex systems, writing or updating system requirement specifications and/or associated system-level design documents is required.
8 years of overall work experience with progressively increasing responsibility
Previous experience working in a medical device company.
Software exp: SQL -C#, JAVA, .NET
Web application experience a must

Knowledge, Skills, and Abilities
Requires comprehensive written and verbal communication skills including, interpersonal, facilitation, presentation, and the ability to converse effectively with all levels of employees.
Must be self motivated with the ability to meet deadlines.
Possess outstanding analytical and problem solving skills.
Demonstrated ability to understand and comply with applicable FDA, IEC and UL regulations and company operating procedures, processes, policies.
Must be able to perform in a distributed, diverse cross-functional team environment

Earn generous salary (DOE) along with a comprehensive benefit package and a great place to work.

If this sounds like you, apply today! 

NG-SEPNM - CyberCoders CyberScientificdf-tc

Experience/Skills
See Above

Other desired skills:
Systems Engineer
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