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Design Assurance Engineer Jobs (NOW HIRING)

Stereotaxis

Design Assurance Engineer

Minneapolis, MN · On-site

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 ...

Hologic

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 ...

Hologic Inc.

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 ...

Veranex

Sr Design Assurance Engineer

Minneapolis, MN · On-site

$93K - $133K/yr

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 ...

Veranex

Sr Design Assurance Engineer

Providence, RI · On-site

$93K - $133K/yr

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 ...

Bracco

Design Assurance Engineer II

Eden Prairie, MN · On-site

The Design Assurance Engineer II position will support design assurance activities for Bracco Medical Technologies (BMT) products. This role is responsible for providing support for Design ...

Philips

Senior Design Assurance Engineer

Plymouth, MN · On-site

$91K - $146K/yr

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 ...

Philips

Senior Design Assurance Engineer

Plymouth, MN

$91K - $146K/yr

Job TitleSenior 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 ...

Medtronic

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 ...

New

Nextern

Senior Design Assurance Engineer

Maple Grove, MN · On-site

$115K - $130K/yr

The Senior Design Assurance Engineer is responsible for design quality input and deliverables for new product development programs throughout the product lifecycle. They will also support sustaining ...

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Design Assurance Engineer information

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How much do design assurance engineer jobs pay per hour?

As of Jul 21, 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 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 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.

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Design Assurance Engineer jobs near you
Infographic showing various Design Assurance Engineer job openings in the United States as of July 2026, with employment types broken down into 83% Full Time, and 17% Contract. Highlights an 100% In-person job distribution, with an average salary of $105,435 per year, or $50.7 per hour.
Design Assurance Engineer

Design Assurance Engineer

Ativa Medical Corporation

Saint Paul, MN

Full-time

Re-posted 28 days ago

Job description

Design Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.

Essential Job Duties & Skills:

· Work with the product development team(s) in conducting risk analysis activities such as Design FMEAs, Process FMEAs, Hazard Analysis, and User Risk Analysis.

· Manage tracability of design requirements through risk mitigation and design verification

· Technical writing and critical review of design verification plans, procedures, test protocols and reports.

· Critical review of design and process documents and records such as procedures, specifications, drawings and various Design History File records

· Lead key equipment qualification efforts

· Lead supplier management activities

· Review and evaluate non-conforming materials.

· Work with vendors to correct material non-conformances

· Generate inspection procedures for both incoming parts and on-site production.

· Review manufacturing documentation for accuracy and clarity.

· Contribute to process validation activities

· Proficient knowledge and use of applicable industry standards specifically, ISO 13485 for Quality Systems, and ISO 14971 for Risk Management

· Proficient in MS Office Suite including but not limited to MS Outlook, MS Word MS Excel, MS PowerPoint.

Additional Job Expectations:

· Being aligned with team goals and supportive in a team environment

· Sound communication in collaborations with other company functions (written and verbal)

· Using good judgment when confronted with choices

· Being organized, thorough in prioritizing and generating work products

· Being both proactive and professional

Education and Experience:

· BS in Mechanical Engineering or a related field

· 5+ years of Design Assurance in Life Sciences Industry
IVD medical device environment a plus

· Experience with statistical methods and terminology

· Demonstrated structured problem-solving skills