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.
Quick apply
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.
Quick apply
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.
Saint Paul, MN · On-site
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.
Quick apply
Saint Paul, MN · On-site
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.
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 ...
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 ...
San Diego, CA · On-site
$123K - $143K/yr
Job TitleSenior Design Assurance Engineer Senior Design Assurance Engineer As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS ...
San Diego, CA · On-site
$123K - $143K/yr
Job TitleSenior Design Assurance Engineer Senior Design Assurance Engineer As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System (QMS ...
San Diego, CA · On-site
$123K - $143K/yr
Job Title Senior Design Assurance Engineer Senior Design Assurance Engineer As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System ...
San Diego, CA · On-site
$123K - $143K/yr
Job Title Senior Design Assurance Engineer Senior Design Assurance Engineer As a Design Assurance Quality Engineer, the primary responsibility will be to work within the Quality Management System ...
Maple Grove, MN · On-site
Senior Design Assurance Engineer - Medical Device (Onsite - Arbor Lakes, MN) Contract Overview: From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology ...
Maple Grove, MN · On-site
Senior Design Assurance Engineer - Medical Device (Onsite - Arbor Lakes, MN) Contract Overview: From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
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 ...
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 ...
Elgin, IL · On-site
Sr. Design Assurance Engineer Position type: Full-time Type of contract: Permanent HARTING stands for strong connections - across the globe. As one of the leading international suppliers of ...
Elgin, IL · On-site
Sr. Design Assurance Engineer Position type: Full-time Type of contract: Permanent HARTING stands for strong connections - across the globe. As one of the leading international suppliers of ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
We have a high-impact opportunity for a Senior Design Assurance Engineer to lead design assurance efforts for the Opal system, a critical medical device platform. This role requires a self-driven ...
Plymouth, MN · On-site
$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 ...
Plymouth, MN · On-site
$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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
Quick apply
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 ...
Fridley, MN · On-site
$110K - $160K/yr
About the role The Principal Design Assurance Engineer supports product design and development activities and ensures the effective transfer of new products into manufacturing. This role partners ...
Fridley, MN · On-site
$110K - $160K/yr
About the role The Principal Design Assurance Engineer supports product design and development activities and ensures the effective transfer of new products into manufacturing. This role partners ...
$18.03 - $23.08
1% of jobs
$23.08 - $28.13
2% of jobs
$28.13 - $33.17
7% of jobs
$33.17 - $38.22
11% of jobs
$39.68 is the 25th percentile. Wages below this are outliers.
$38.22 - $43.27
14% of jobs
$43.27 - $48.32
15% of jobs
The median wage is $48.51 / hr.
$48.32 - $53.37
14% of jobs
$53.37 - $58.41
8% of jobs
$59.90 is the 75th percentile. Wages above this are outliers.
$58.41 - $63.46
12% of jobs
$63.46 - $68.51
12% of jobs
$68.51 - $73.56
5% of jobs
$18
$50
$73
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.
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.
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.

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
Sourced by ZipRecruiter
11 - 50 Employees
Saint Paul, MN, US
2008