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Design Assurance Engineer Jobs (NOW HIRING)

Hologic

Design Assurance Engineer 3

Marlborough, MA · On-site

$97K - $152K/yr

Provide design assurance support for new product development and on market medical devices. This ... Technical Bachelor Degree, Electrical or Software Engineering preferred * 2-5 years' experience ...

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How much do design assurance engineer jobs pay per hour?

As of Jun 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 does a design assurance engineer do?

A design assurance engineer ensures that product designs meet quality, safety, and regulatory standards throughout development. They review design processes, perform risk assessments, and verify compliance using tools like FMEA and design reviews. This role often requires knowledge of industry standards and collaboration with cross-functional teams to prevent defects and ensure reliable product performance.

What is a Design Assurance Engineer job?

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 in the Design Assurance Engineer position, and why are they important?

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 engineers make $300,000 a year?

Senior engineers in specialized fields such as software engineering, petroleum engineering, and aerospace engineering can earn $300,000 or more annually, especially with extensive experience, advanced skills, and in high-demand industries. Executive-level engineering roles or those with significant managerial responsibilities may also reach or exceed this salary level.

What are the primary responsibilities of a Design Assurance Engineer on a typical project team?

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.

What engineers make $500,000?

Senior engineers in specialized fields such as software engineering, petroleum engineering, and aerospace engineering can earn $500,000 or more annually, especially with experience, advanced skills, and leadership roles. High compensation often includes bonuses, stock options, or profit sharing, particularly in technology and energy sectors.

Do QA engineers make good money?

Quality Assurance (QA) engineers, including those in design assurance roles, typically earn competitive salaries that vary by industry, experience, and location. They often have skills in testing tools, automation, and quality standards, which can influence earning potential. Overall, QA engineering is considered a well-paying profession within engineering and technology fields.
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Design Assurance Engineer jobs near you
Infographic showing various Design Assurance Engineer job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 77% Full Time, 17% Part Time, and 5% Contract. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $105,435 per year, or $50.7 per hour.
Design Assurance Engineer

Design Assurance Engineer

Stereotaxis

Minneapolis, MN

Full-time

Posted 7 days ago

Job description

Company Description: Stereotaxis is the global leader in innovative robotic technologies designed to enhance the treatment of arrhythmias and perform endovascular procedures. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information.

Core components of Stereotaxis' systems have received regulatory clearance in the United States, European Union, China, Japan, Canada, and elsewhere. For more information, please visit www.stereotaxis.com. Position Summary: The Design Assurance Engineer directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product

Essential Responsibilities: Manage deliverables from the design process including DHF and Engineering Project File documents. Collaborate with design engineers and technicians in the development of verification/validation protocols. Participate on design teams to assure product requirements as well as quality requirements are documented and addressed.

Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments. Provide direction in implementing Incoming Inspection plan, First Article Inspection plans, In-Process and Final Product Inspection. Assist with the development / update of FMEA and Hazard Analysis in conjunction with other engineering departments.

Lead the development of quality plan specific to each project. Assist with the development of inspection processes and equipment including test fixtures. Train company employees on Quality related activities.

Other duties as assigned.Qualifications & Skills: Bachelor's Degree/Technical Degree in Engineering. Minimum 5 years medical device experience in manufacturing/quality/product development; catheter manufacturing and development preferred. Working knowledge of FDA/cGMP and MDD regulations/guidelines, and International Standards

Experience with design verifications/validations. Experience with all aspects of Risk Management throughout the lifecycle. Experience with Quality Management System software.

Must possess good project management skills and initiative in taking on and completing projects. Strong verbal and written communication skills. Must be able to manage and prioritize multiple projects/objectives.

Legally authorized to work in the United States Work Conditions: This role is an in-office position at Stereotaxis' Rogers MN facility. Culture: Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.Qualifications & Skills: Bachelor's Degree/Technical Degree in Engineering

Minimum 5 years medical device experience in manufacturing/quality/product development; catheter manufacturing and development preferred. Working knowledge of FDA/cGMP and MDD regulations/guidelines, and International Standards. Experience with design verifications/validations.

Experience with all aspects of Risk Management throughout the lifecycle. Experience with Quality Management System software. Must possess good project management skills and initiative in taking on and completing projects.

Strong verbal and written communication skills. Must be able to manage and prioritize multiple projects/objectives. Legally authorized to work in the United States Work Conditions: This role is an in-office position at Stereotaxis' Rogers MN facility.

Culture: Stereotaxis values steadfast integrity, intellectual excellence, responsiveness and reliability, and a dedication to constant improvement. We take pride in the positive impact of our work and in building a collaborative and innovative work environment that embraces challenge.

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