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Design Quality Engineer Jobs in Boston, MA (NOW HIRING)

Mondo

Senior Software Design Quality Engineer

Danvers, MA · On-site

$110K - $160K/yr

Senior Software Design Quality Engineer Start Date: ASAP Salary Range: $110,000 - $160,000/year Travel: Onsite 3 days per week in Danvers, MA Benefits: Eligible for Health, Dental, Vision, 401K, PTO ...

Mondo

Senior Software Design Quality Engineer

Danvers, MA · On-site

$110K - $160K/yr

Senior Software Design Quality Engineer Start Date: ASAP Salary Range: $110,000 - $160,000/year Travel: Onsite 3 days per week in Danvers, MA Benefits: Eligible for Health, Dental, Vision, 401K, PTO ...

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All JobsDesign Quality Engineer JobsDesign Quality Engineer Jobs in Boston, MA

Design Quality Engineer information

See Boston, MA salary details

$20

$51

$75

How much do design quality engineer jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for design quality engineer in Boston, MA is $51.26, according to ZipRecruiter salary data. Most workers in this role earn between $42.02 and $61.35 per hour, depending on experience, location, and employer.

What is a design quality engineer?

Design Quality Engineers are professionals who ensure that products are developed and manufactured according to quality standards and regulatory requirements. They work closely with design, engineering, and manufacturing teams to identify potential risks, implement quality controls, and validate product designs. Their goal is to make sure that products are safe, effective, and meet customer expectations before they are released to the market.

What are the key skills and qualifications needed to thrive as a design quality engineer?

To thrive as a Design Quality Engineer, you need a solid background in engineering principles, quality assurance methodologies, and a relevant degree such as mechanical or electrical engineering. Familiarity with standards like ISO 13485 or ISO 9001, proficiency in tools such as FMEA, risk analysis software, and statistical analysis platforms like Minitab are typically required. Strong problem-solving abilities, attention to detail, and effective communication skills help distinguish top performers in this role. These skills ensure that products meet regulatory requirements, maintain high quality standards, and minimize risk throughout the design and development process.

How does a design quality engineer typically collaborate with cross-functional teams during product development?

As a Design Quality Engineer, you work closely with teams such as R&D, manufacturing, regulatory affairs, and supply chain throughout the product development lifecycle. Your primary role is to ensure quality standards are integrated from the initial concept through to product launch. This often involves participating in design reviews, facilitating risk assessments like FMEA, and ensuring compliance with relevant regulations. Effective communication and problem-solving skills are essential, as you'll help bridge gaps between design intent and manufacturability to ensure a smooth transition to production.

What is the difference between Design Quality Engineer vs Manufacturing Quality Engineer?

AspectDesign Quality EngineerManufacturing Quality Engineer
Primary FocusEnsuring product design meets quality standards and specifications during developmentMonitoring and improving quality in manufacturing processes and final products
Work EnvironmentDesign labs, R&D departments, product development teamsProduction lines, manufacturing plants, quality control departments
Required CredentialsBachelor's in Engineering, Quality certifications (e.g., CQE), knowledge of design standardsBachelor's in Engineering or Manufacturing, Quality certifications, process improvement skills

Design Quality Engineers focus on product design and development to prevent defects early, while Manufacturing Quality Engineers concentrate on maintaining quality during production. Both roles require similar credentials and work within quality assurance but target different stages of the product lifecycle.

What are the most commonly searched types of Design Quality Engineer jobs in Boston, MA?

The most popular types of Design Quality Engineer jobs in Boston, MA are:

What are popular job titles related to Design Quality Engineer jobs in Boston, MA?

For Design Quality Engineer jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Design Quality Engineer jobs in Boston, MA look for?

The top searched job categories for Design Quality Engineer jobs in Boston, MA are:

Design Quality Engineer jobs near you
Infographic showing various Design Quality Engineer job openings in Boston, MA as of August 2026, with employment types broken down into 1% As Needed, 80% Full Time, 13% Part Time, 5% Contract, and 1% Nights. Highlights an 87% Physical, 2% Hybrid, and 11% Remote job distribution, with an average salary of $106,611 per year, or $51.3 per hour.

Senior Software Design Quality Engineer

Marlborough, MA • On-site

Hologic
Health Care and Social Assistance • 5 - 10K employees
Learn more about Hologicexternal

Full-time

This job post has expired today. Applications are no longer accepted.

Hologic rating

8.0

Company rating: 8.0 out of 10

Based on 25 frontline employees who took The Breakroom Quiz

182nd of 499 rated machine equipment manufacturers

Job description


Position Summary
The Senior Software Design Quality Engineer serves as a senior Design Quality authority for software-enabled in-vitro diagnostics (IVD) medical devices across the development lifecycle. This includes software-enabled diagnostic systems incorporating image analysis and AI/ML-based algorithms to support detection and classification of cellular abnormalities. Embedded on New Product Development (NPD) core teams, this role owns software design controls, drives integration of ISO 14971 risk management into the software development lifecycle (SDLC), and ensures alignment to IEC 62304 and applicable Software as a Medical Device (SaMD) expectations. Post-market signals are leveraged as structured inputs to design improvements. Ensures traceability and alignment across design inputs, verification, and validation to meet regulatory expectations under all applicable design and development regulations and standards.
Foundations of Success
  1. Lead with Ownership: Demonstrate accountability and integrity in all actions.
  2. Act with Speed: Drive timely, effective solutions and keep stakeholders informed.
  3. Foster Partnerships: Build strong, collaborative relationships across functions.
  4. Delight Customers: Champion innovative, customer-centric improvements.
  5. Celebrate Wins: Inspire and recognize impactful results and team achievements.

Essential Duties and Responsibilities
The incumbent may be required to perform additional duties related to the functions listed below:
Software Design Quality Ownership
  • Serves as Design Quality representative on software NPD core teams.
  • Owns design quality strategy for new and modified software-enabled products.
  • Ensures design inputs are complete, testable, and aligned to intended use.
  • Ensures design outputs are appropriately translated into production specifications.
  • Approves software design quality deliverables, including design inputs, risk analyses, V&V strategy, and design reviews.

Risk Management Integration
  • Owns software-related risk management activities per ISO 14971.
  • Ensures traceable linkage between hazards, design requirements, and verification evidence.
  • Maintains risk files with production and post-production feedback per ISO 14971 Section 10.

Verification and Validation Strategy
  • Approves risk-based V&V approaches for software systems.
  • Ensures validation reflects real-world use conditions and user needs.
  • Confirms V&V coverage is traceable to requirements and identified hazards.
  • Determines adequacy of verification and validation evidence relative to intended use and risk.

Software and System Behavior
  • Leads analysis of software-related failure modes, with focus on real-world use conditions and system interactions.
  • Drives design improvements to strengthen system robustness, error handling, and user-visible behavior.
  • Ensures software and system behavior are sufficiently defined and diagnosable to support effective investigation of field issues.

Post-Market Signal Integration
  • Reviews software-related complaint trends and field signals as inputs to design.
  • Translates signals into design improvements, risk file updates, or verification gap closure.
  • Engages in complaint investigations where software or system behavior indicates potential design or risk control gaps.

Cross-Functional Leadership
  • Drives alignment across R&D, Systems, Regulatory, and Service.
  • Influences product decisions to improve quality, reliability, and compliance.
  • Mentors junior engineers on software design quality practices.
  • Serves as the quality authority in design reviews, providing independent oversight per ISO 13485 design control expectations.

Requirements / Qualifications
Qualifications will be assessed holistically, and equivalent education, experience, and demonstrated skills may fulfill these requirements.
  • Bachelor's degree in computer science, software engineering, or related technical discipline; advanced degree preferred.
  • 8+ years of experience in quality, software, or systems engineering within the medical device or comparable regulated industry.
  • Demonstrated experience in software NPD / design assurance activities in regulated medical devices, including design controls and risk management.
  • Deep working knowledge of ISO 13485, FDA QMSR (21 CFR 820), ISO 14971, and IEC 62304.
  • Proven experience translating field issues into design changes and closed-loop risk updates.
  • Experience with SaMD and QI/ML-enabled medical devices preferred; familiarly with FDA guidance on AI/ML and the EU Act is a plus.
  • Strong technical leadership, cross-functional influence, and written communication skills.
  • Experience with software system architecture, interfaces, and failure modes in complex electromechanical systems.
  • Preferred certifications: ASQ CQE or CSQE, or a comparable quality or reliability certification.

Why join Hologic?
We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.
The annualized base salary range for this role is $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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Hologic is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.

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