Senior Software DQE Engineer
Danvers, MA
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:
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Support next-generation console platform (firmware-focused)
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Attend daily/regular scrum meetings
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Review and approve test protocols, test cases, design documentation, and code reviews
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Oversee software deliverables tied to the quality system
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Ensure SDLC deliverables align with IEC 62304 requirements
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Own patient/software risk management activities (ISO 14971)
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Assess software requirements and technical alignment
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Identify process gaps before downstream impact
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Ensure correct software classification and risk controls
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Partner with firmware teams (U.S. and Germany) and internal SDQE team
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Provide quality oversight across the digital platform
Requirements:
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Must-Haves:
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Strong Design Quality (SDQE) experience within medical devices
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Deep understanding of software SDLC and IEC 62304 compliance
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Experience with software risk management and ISO 14971
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Ability to assess technical requirements and evaluate patient/software risk
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Knowledge of software classification and quality system deliverables
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Experience reviewing code and software architecture documentation
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Ability to challenge engineering teams technically (non-coding role)
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Understanding of cybersecurity principles, including threat modeling and design flow modeling
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Medical device experience (Class II or III; Class 3 preferred)
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Nice-to-Haves:
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Experience supporting firmware-heavy platforms
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Experience in global team collaboration
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Prior experience supporting long-term product roadmap initiatives
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