Systems Engineer

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Systems Engineer

  • Specialty:

    Engineering
  • Title:

    Systems Engineer
    • City:

      Watertown
    • State:

      MA
    • Zip Code:

      02472
  • Start date:

    12-18-2018
  • Status:

    Closed
  • Assignment Type:

    Direct Hire
  • Job Id:

    47478

Description

We are looking for a Systems Engineer to join our client located in Watertown, Ma on a direct hire basis. You will be part of developing a non-invasive patient monitoring system capable of providing a dramatically more complete monitoring solution.

Responsibilities:

  • Work closely with customers to identify and prioritize needs        
  • Develop/maintain the system level requirements to satisfy customer needs
  • Develop/maintain system architecture for the products
  • Define subassembly interfaces and allocate subassembly requirements to design teams
  • Efficiently use complete requirement management and tracing
  • Develop/maintain the risk management file in accordance with ISO 14971 and ensure product safety
  • Provide technical leadership to design team, understanding product, project, customer, and business impact   
  • Responsible for planning, managing and implementing V&V tasks

Qualifications:

  • BS Degree in Engineering (Biomedical, Electrical/Software, or Mechanical)
  • 7+ years of engineering experience
  • Experience working with translating customer needs into design requirements and architecture
  • Experience applying risk management methodologies including DFMEA and Risk/Hazard Analysis
  • Experience working in a Medical Device environment
  • Demonstrated experience working on new product development projects resulting in successful products in compliance with FDA or other regulatory bodies. Background in 13485 QMS, IEC60601-1 System Safety, IEC60601-1-2 EMC and 62304 Software Development Processes.
  • Demonstrated leader with strong organizational and communication skills
  • Strong interpersonal skills with the ability to work collaboratively with others in a team environment
  • Experience in the medical device industry
  • Experience with project management

 

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