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Design Assurance Engineer Jobs (NOW HIRING)

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 ...

Endologix

Principal Design Assurance Engineer

Santa Rosa, CA · On-site

$147K - $197K/yr

Join our Quality team as the Principal Design Assurance Engineer at Endologix! WHO WE ARE: Endologix LLC is a California-based global medical device company dedicated to improving patients' lives ...

Envista

Design Assurance Engineer II

Pomona, CA · On-site

$95K - $116K/yr

The Design Assurance Engineer II supports the development, manufacturing, and lifecycle management of dental consumables by ensuring design control, risk management, quality, and regulatory ...

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 ...

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 ...

IPG Photonics

Design Assurance Engineer

Marlborough, MA · On-site

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 ...

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 ...

Integer

Design Assurance Engineer III

Plymouth, MN

... engineers and managers in your organization. You will learn the application of design assurance and product test development and testing concepts in the design & manufacture of Integers product lines.

Integer

Design Assurance Engineer II

Clarence, NY

The Design Assurance Engineer will ensure a successful transfer of newly developed product to production, while supporting design phases concept through launch. * You adhere to Integer's Values and ...

Abbott

Design Assurance Engineer II

Plymouth, MN

As a Design Assurance Engineer II based in Plymouth, MN, you will play a critical role in ensuring the safety, efficacy, and compliance of cutting-edge electrophysiology products. You will be ...

Abbott

Design Assurance Engineer II

Plymouth, MN

As a Design Assurance Engineer II based in Plymouth, MN, you will play a critical role in ensuring the safety, efficacy, and compliance of cutting-edge electrophysiology products. You will be ...

Abbott

Design Assurance Engineer II

Plymouth, MN · On-site

As a Design Assurance Engineer II based in Plymouth, MN, you will play a critical role in ensuring the safety, efficacy, and compliance of cutting-edge electrophysiology products. You will be ...

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How much do design assurance engineer jobs pay per hour?

As of Aug 12, 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.

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Design Assurance Engineer jobs near you
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 II

Bracco

Eden Prairie, MN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 10 days ago

Job description

Why Join Bracco Medical Technologies?
We care as much about our employees as we do our patients. Our culture fosters a work environment where employees can thrive, be passionate and have fun along the way. Each member of the Bracco Medical Technologies team has the power to make a difference......every day!
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 Verification and Validation activities while ensuring compliance with BMT design control procedures and applicable regulations and external standards.
Primary Duties & Responsibilities:
Design Assurance
  • Provide direction and technical expertise to product development teams regarding quality characteristics and conformance to product requirements associated to medical devices or software as a medical device (SaMD) products.
  • Drive the Design Control process and own the Design and Development File (DDF) within the framework of regulatory requirements.
  • Ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
  • Provide guidance and support for design verification and validation activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes, and quality of the test spec.
  • Lead risk management activities from planning, analysis and verification, and risk reporting and acceptance for the assigned areas of responsibility.
  • Provide support for testing qualification, technical standards interpretation, and appropriate statistical methods, including sample size determination.
  • Generate the QA deliverables to meet the project scope and plan.
  • Review, provide input, and approve project-related deliverables and change orders.
  • Work with external design/test organizations to ensure Design Control requirements are fulfilled and appropriate supplier controls are in place.
  • Document and report defects found during testing or from post-market activities. Provide risk assessment for the defects and work with the development team to ensure they are resolved.
  • Review Design History Files and Technical Files for conformance to applicable requirements.
  • Prepare technical sections of regulatory approval applications by identifying the testing needed to support global submission, and identifying U.S. and non U.S. product and safety standards.
  • Rigorous documentation for all phases of new product development including specifications, verification/validation test plans, and change orders associated with medical devices and consumable products.
  • Routine communication with peers and supervisors including documentation of work, meetings, and decisions.

Qualifications (Knowledge, Skills & Abilities):
Minimum
  • B.S. in Engineering (electrical or mechanical), Computer Science, or comparable science discipline
  • Minimum of 3+ years of Quality Engineering experience in the medical device industry
  • Advanced working knowledge with ISO 13485 quality system requirements and FDA quality system regulations 21CFR 820.
  • Working knowledge of quality tools (e.g., Six Sigma, DOE, process analysis/capability, FMEA, FTA)
  • Knowledge of risk management and ISO14971
  • Strong written and verbal communication skills to effectively translate ideas, concepts and technical information to both internal and external parties, and across all levels of an organization.
  • Advanced problem solving skills
  • Ability to develop and deliver clear, concise, and timely oral and written reports to peers and management
  • Ability to work independently

Preferred:
  • Advanced degree in Electrical Engineering or Computer Science
  • Quality Engineering experience with medical devices which incorporate electrical, mechanical, and software components
  • Demonstrated project management skills in order to plan, conduct and implement system assessments
  • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
  • Knowledge of IEC 60601 and UL Standards
  • Knowledge and proficiency in the application of AAMI TIR 36, EN 62304, EN 62366, EN 82304, IEC/TR 80002-1, and other standards, regulations and guidance related to validation of software and computerized systems
  • Demonstrated knowledge and proficiency in the application of 21 CFR Part 11, IPSE GAMP, ISO 14971, and other standards, regulations and guidance related to validation of software computerized systems.
  • Familiarity with SDLC processes and methodologies, especially the application of Agile methods in the development of medical device software
  • Experience with cybersecurity, knowledgeable in HIPAA regulations and GDPR, and related data protection policies

Other:
  • Ability to travel both domestically and internationally, at times overnight, may be required. Travel is expected to be less than 10%.

Compensation & Total Rewards:
Estimated Starting Salary Range: $95,000 - 104,000
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
  • Paid Time Off, Company Holidays & Paid Family Leave - We provide PTO and Company Holidays to help you recharge, relax and do what's important to you, when it's important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
  • Achieve - Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
  • Live well - We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
  • Evolve - Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you'll find many opportunities to grow, personally and professionally.
  • Choose - You won't find "stuffy" here-whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.

Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.

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