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Design Assurance Engineer Jobs (NOW HIRING)

Job Title Design Assurance Engineer Location(s) Covaris - Woburn - MA Covaris, LLC., a PerkinElmer company, is a profitable and rapidly growing technology company headquartered in Woburn ...

Job Title Design Assurance Engineer Location(s) Covaris - Woburn - MA Covaris, LLC., a PerkinElmer company, is a profitable and rapidly growing technology company headquartered in Woburn ...

Shift Type Job Title Design Assurance Engineer Education Bachelor's Degree Location Minneapolis, MN 55401 US (Primary) Career Level Experienced (Non-Manager) Category Engineering Date Needed By Job ...

Lead Design Assurance Engineer

Newark, DE · On-site

$119K - $186K/yr

At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and global regulatory compliance are ...

Lead Design Assurance Engineer

Newark, DE · On-site

$119K - $186K/yr

At Hologic, we are seeking a Lead Design Assurance Engineer to play a pivotal role in new product development, ensuring that design controls, risk management, and global regulatory compliance are ...

The Design Assurance Engineer is responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance. Ensures ...

The Design Assurance Engineer is responsible for accurate, independent generation and evaluation of risk management, design history file documentation and overall quality system compliance. Ensures ...

Job Title Senior Design Assurance Engineer The Senior Design Assurance Engineer will play a critical role in support of the design controls process, with a focus on Sustaining and New product ...

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Design Assurance Engineer - Design Verification Focus Location: TX Duration: 6+ Months with possibility of extension Hours per week: 40 Our client is seeking a Design Verification Engineer to support ...

Be Seen First

Design Assurance Engineer - Design Verification Focus Location: TX Duration: 6+ Months with possibility of extension Hours per week: 40 Our client is seeking a Design Verification Engineer to support ...

Principal Design Assurance Engineer

Moundsview, MN · On-site

$143K - $191K/yr

A Day in the Life Medtronic's Interventional Cardiology Therapy (ICT) Operating unit is looking for a Principal Design Assurance Engineer to be part of a high-performing team that is revolutionizing ...

Support Design Engineering in the creation of Design History and Technical Files * Interact with third-party test houses that conduct compliance testing of IPG products * Assist regulatory department ...

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Design Assurance Engineer information

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How much do design assurance engineer jobs pay per hour?

As of Aug 11, 2026, the average hourly pay for design assurance engineer in the United States is $50.69, according to ZipRecruiter salary data. Most workers in this role earn between $39.18 and $61.78 per hour, depending on experience, location, and employer.

What is a design assurance engineer?

A Design Assurance Engineer ensures that products meet regulatory standards, quality requirements, and design specifications throughout development. They collaborate with design, manufacturing, and quality teams to identify risks, implement process improvements, and ensure compliance with industry standards like ISO 13485 or AS9100. Their role includes risk management, validation, verification, and documentation to ensure product reliability and safety.

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

To thrive as a Design Assurance Engineer, you need expertise in quality assurance, regulatory compliance, risk management, and a solid engineering background, typically supported by a bachelor’s degree in engineering or a related field. Familiarity with industry standards such as ISO 13485, knowledge of design control processes, and proficiency in tools like FMEA and statistical analysis software are highly valued, along with certifications such as ASQ CQE. Strong attention to detail, problem-solving, communication skills, and the ability to collaborate across multidisciplinary teams set top candidates apart. These skills ensure products meet regulatory standards and customer requirements while minimizing product risks and ensuring successful project outcomes.

What are the primary responsibilities of a design assurance engineer?

As a Design Assurance Engineer, you are responsible for ensuring that all product design activities comply with regulatory requirements and internal quality standards throughout the development lifecycle. This includes reviewing and approving design documents, participating in risk analyses, ensuring effective implementation of design controls, and collaborating with cross-functional teams such as R&D, manufacturing, and regulatory affairs. You may also be involved in conducting root cause investigations for product non-conformances and supporting audits or inspections. This role is crucial for maintaining product quality and safety, and provides opportunities to work on innovative projects and advance into roles with greater responsibility in quality assurance or regulatory affairs.

More about Design Assurance Engineer jobs
What cities are hiring for Design Assurance Engineer jobs? Cities with the most Design Assurance Engineer job openings:
What states have the most Design Assurance Engineer jobs? States with the most job openings for Design Assurance Engineer jobs include:
Infographic showing various Design Assurance Engineer job openings in the United States as of August 2026, with employment types broken down into 1% Internship, 88% Full Time, 6% Part Time, and 5% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $105,435 per year, or $50.7 per hour.

Design Assurance Engineer

PerkinElmer

Woburn, MA • On-site

Full-time

Posted 16 days ago


PerkinElmer rating

8.3

Company rating: 8.3 out of 10

Based on 7 frontline employees who took The Breakroom Quiz


Job description

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.
Job Title
Design Assurance Engineer
Location(s)
Covaris - Woburn - MA
Job Description
Covaris, LLC., a PerkinElmer company, is a profitable and rapidly growing technology company headquartered in Woburn, Massachusetts.Covaris developed the proprietary and patented Adaptive Focused Acoustics™ (AFA) technology platform, holding a leadership position in sample preparation for DNA sequencing and providing significant benefits to drug delivery and formulation development. For more information, visit www.covaris.com.
Summary:
As Design Assurance Engineer, you will lead Design Assurance activities for new product introduction (NPI) and sustaining engineering projects. You will be an active contributor for on multiple development teams. You will be involved in multiple ongoing projects, including reagents, kits, consumables and instruments manufactured by Covaris in Massachusetts.
Essential Responsibilities:
The employee may be required to perform all or a combination of the following essential responsibilities as determined by business necessity:
• Lead design assurance activities for new product development and sustaining engineering projects
• Work closely with R&D, Engineering and Manufacturing on design, testing, and verification activities
• Represent Quality at Core Team level.
• Manage Design History file and Design Transfer deliverables
• Lead risk management activities including FMEA, risk mitigation, and effectiveness checks
• Support design transfer, process validation, and test method validation
• Collaborate with Commercial, Supply Chain, Manufacturing, and Quality teams
• Track and support multiple NPI and sustaining engineering projects
• Drive continuous improvement in quality and design assurance processes
Preferred Qulaifications:
• 5+ years of Design Assurance or Product Development experience in a regulated industry (Medical Device, IVD, Aerospace, Automotive, etc.)
• Strong knowledge of new product development and close collaboration with R&D
• Solid understanding of global regulations and standards: ISO 13485, ISO 14971, IEC 60601
• Experience working with cross-functional and global teams
• Bachelor's degree in Mechanical, Electrical, Biomedical Engineering, or related field
• Proactive, detail-oriented, and solution-driven
• Proficiency in Microsoft Office
• Must be based in Boston area
Reasonable Accommodation:
Covaris is committed to the spirit and the letter of the Americans with Disabilities Act. All requirements are subject to possible modification to reasonably accommodate otherwise qualified individuals
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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