Senior Software DQE Engineer

Apply now: Senior Design Quality Engineer (Software/Firmware), location is Hybrid (Danvers, MA open to remote flex). The start date is ASAP for this 6–12 month contract position.

Job Title: Senior Design Quality Engineer (Software/Firmware)
Location-Type: Hybrid (Danvers MA, remote flex)
Start Date Is: ASAP
Duration: 6–12 Months (Contract), opportunity to transition perm
Compensation Range: $65-$80, open to discussion**

Job Description:
The Senior Design Quality Engineer will support a global leader in heart recovery technologies focused on advancing next-generation circulatory support systems. This role provides software and firmware design quality oversight for a flagship console platform that will drive the product roadmap for years to come, ensuring SDLC compliance, risk management alignment, and adherence to regulatory standards.

Day-to-Day Responsibilities:

• Support next-generation console platform (firmware-focused)
  
  

• Attend daily/regular scrum meetings
  
  

• Review and approve test protocols, test cases, design documentation, and code reviews
  
  

• Oversee software deliverables tied to the quality system
  
  

• Ensure SDLC deliverables align with IEC 62304 requirements
  
  

• Own patient/software risk management activities (ISO 14971)
  
  

• Assess software requirements and technical alignment
  
  

• Identify process gaps before downstream impact
  
  

• Ensure correct software classification and risk controls
  
  

• Partner with firmware teams (U.S. and Germany) and internal SDQE team
  
  

• Provide quality oversight across the digital platform
  
  

Requirements:

• Must-Haves:
  
  

  • Strong Design Quality (SDQE) experience within medical devices
    
    

  • Deep understanding of software SDLC and IEC 62304 compliance
    
    

  • Experience with software risk management and ISO 14971
    
    

  • Ability to assess technical requirements and evaluate patient/software risk
    
    

  • Knowledge of software classification and quality system deliverables
    
    

  • Experience reviewing code and software architecture documentation
    
    

  • Ability to challenge engineering teams technically (non-coding role)
    
    

  • Understanding of cybersecurity principles, including threat modeling and design flow modeling
    
    

  • Medical device experience (Class II or III; Class 3 preferred)
    
    

• Nice-to-Haves:
  
  

  • Experience supporting firmware-heavy platforms
    
    

  • Experience in global team collaboration
    
    

  • Prior experience supporting long-term product roadmap initiatives