Systems Engineer Contractor

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This is a temporary contracted position for approx. 3-4 months.

Responsibilities

•   Ability to work within predefined system architecture and effectively execute delegated tasks in a timely and technically solid method
•   Review design changes, work instructions, failure modes and identify areas to update risk file
•   Perform system level of Verification
•   Perform off-site standards compliance testing
•   Collaborate with engineers to understand the impact of design changes on the device's functionality, safety, and manufacturability
•   Hands on engineer
•   Conduct thorough analysis to support design change decisions, with a particular focus on need for risk assessment and verification
•   Update Hazard Analysis and other supporting analysis (UFMEA, SFMEA, DFMEA) based upon inputs from risk lead
•   Update SOPS based upon input from Risk Lead
  
  

Qualifications

•   Bachelor's degree in engineering or a related field
•   At least 3 years within medical device development
•   Experience with IEC 6060-1-2
•   Strong experience with System Level with requirements V&V
•   Strong understanding of engineering principles and electromechanical systems
•   Excellent attention to detail and ability to identify potential problems
•   Effective communication and collaboration skills
•   Ability to work independently and as part of a team
•   Familiarity and execution with ISO 14971
•   Demonstrated experience in doing
•   Ability to execute consistently within our Quality Management System
  
  

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