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Design Assurance Engineer Jobs (NOW HIRING)

Hologic Inc.

Manager, Design Assurance

Marlborough, MA

$115K - $139K/yr

This Design Assurance Manager position will oversee a team of engineers supporting new product development and sustaining products, ensuring that products are designed, tested, and manufactured to ...

Hologic

Manager, Design Assurance

Marlborough, MA · On-site

$115K - $139K/yr

This Design Assurance Manager position will oversee a team of engineers supporting new product development and sustaining products, ensuring that products are designed, tested, and manufactured to ...

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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.
Senior Software Design Assurance Engineer

Senior Software Design Assurance Engineer

Abbott

Burlington, MA • On-site

$78K - $156K/yr

Full-time

Medical, Retirement

Posted 17 days ago

Abbott rating

7.9

Company rating: 7.9 out of 10

Based on 136 frontline employees who took The Breakroom Quiz

156th of 528 rated manufacturers

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

The Senior Software Design Assurance Engineer is responsible for supporting product development, executing and maintaining software quality engineering methodologies, and providing quality engineering support for software. The Senior Software Design Assurance Engineer position focuses primarily on software quality but also supports other aspects of product development based on experience.

What You'll Work On

  • Provides technical and quality system guides related to establishing software requirements.
  • Provide quality oversight for software verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, reviewing and approving software test case protocols and reports, reviewing software development plans, and reviewing other system and software documentation.
  • Leads meetings to prioritize, review, and/or approve action plans for addressing issues captured in problem resolution systems during development.
  • Leads risk evaluation and associated management activities related to software development, including Risk assessments (e.g., FMEA), product risk analysis, and mitigation of software issues.
  • Participates in technical and management reviews to ensure design plans, product design, and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design outputs.
  • Provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports, and other documentation as required.
  • May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
  • Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures.
  • Maintains a strong, collaborative partnership with cross-functional team members, especially with R&D.
  • Works as an individual contributor and may provide guidance or oversee the work of other QE team members.
  • Develop and conduct training of company personnel for the divisional software development and validation program.
  • Support audits and lead quality system improvement activities.
  • Additional responsibilities may be assigned as needed.

Required Qualifications:

  • Bachelor's degree in engineering or a technical field
  • Minimum of 5 years related work experience in Quality or a related field.
  • Knowledge of regulations, standards, and guidance affecting medical software and non-medical device software development.
  • Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications:

  • Advanced degree
  • Previous quality engineering experience and demonstrated use of quality tools/methodologies.
  • Experience working in a broader enterprise/cross-division business unit model.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is

$78,000.00 - $156,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations QualityDIVISION:HF Heart FailureLOCATION:United States > Burlington: 23 Fourth AvenueADDITIONAL LOCATIONS:United States > Pleasanton : 6101 Stoneridge DrWORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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