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Senior Software DQE Engineer in Danvers

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Job DescriptionJob Description

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- 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- 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 )

  • Nice-to-Haves:

    • Experience supporting firmware-heavy platforms

    • Experience in global team collaboration

    • Prior experience supporting long-term product roadmap initiatives

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.

Senior Software DQE Engineer in Danvers

Danvers, MA 01923
Full time

Published on 02/20/2026

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