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Design Quality Engineer Medical Device Jobs (NOW HIRING)

Quanterix

Senior Design Quality Engineer

Billerica, MA · Hybrid

$125K - $150K/yr

The Senior Design Quality Assurance Engineer, with instrumentation focus, develops, establishes ... BASIC QUALIFICATIONS: * 5+ years' experience in a Quality function within the Medical Device ...

Collabera

Design Quality Engineer

Plymouth, MN · On-site

... Medical Device Directives (MDD) ISO procedures / Other Nation & International Standards FDA ... Quality Engineering in the medical device industry (or related industry). Familiar with critical ...

Heartflow

Senior Device Quality Engineer

San Francisco, CA · On-site

$160K - $180K/yr

As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical ...

Medtronic

Sr Design Quality Engineer

Lafayette, CO · On-site

$92K - $124K/yr

The Senior Design Quality Engineer plays a critical role in applying Design Controls, Risk ... Experience in the medical device industry or in a regulated industry with similar quality and ...

Socket.dev

Senior Device Quality Engineer

San Francisco, CA · On-site

$150 - $200/hr

As the Senior Device Quality Engineer , you will serve as a key technical lead for software quality and design excellence. You will bridge the gap between rapid Agile development and rigorous medical ...

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How much do design quality engineer medical device jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for design quality engineer medical device in the United States is $47.19, according to ZipRecruiter salary data. Most workers in this role earn between $38.70 and $56.49 per hour, depending on experience, location, and employer.

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Infographic showing various Design Quality Engineer Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, and 6% Contract. Highlights an 87% Physical, 1% Hybrid, and 12% Remote job distribution, with an average salary of $98,145 per year, or $47.2 per hour.

Design Quality Engineer (DQE)-Andover, MA

Andover, MA • On-site

Ztek Consulting INC
See more jobs at Ztek Consulting INCexternal

$72K - $94K/yr

Contractor

Re-posted yesterday

Job description

Role: Design Quality Engineer (DQE)

Work location: Andover, MA

Type of hire: Contract

Job Description:

  • Working from client office: Yes (Hybrid 3 days per week).
  • Qualifications:
  • Bachelor’s degree in Engineering (Biomedical, Software, Systems) or a related technical discipline
  • Advanced degree (Master’s) in Engineering, Quality, or Regulatory Affairs preferred
  • Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus

Job Description

As a Design Quality Engineer (DQE) for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end‑to‑end design quality and compliance across the product development lifecycle for Class II/III medical devices, including software-driven and active implantable products. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post‑market activities.

Key Responsibilities

In this role you will play a key role in:

  • Serving as the quality lead on product development teams, ensuring compliance with design controls across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
  • Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
  • Leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
  • Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
  • Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
  • Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
  • Leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
  • Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Required Skills

  • 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)
  • Strong hands‑on experience with design controls, DHF management, and traceability in regulated environments
  • Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)
  • Experience supporting software quality within the SDLC and understanding of software risk management principles
  • Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development
  • Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation
  • Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
  • Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes