Senior Software Design Assurance Engineer

Thornton Tomasetti; Burlington (VT); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Career development

Free HIP PPO medical coverage

Tuition reimbursement

Freedom 2 Save student debt program

FreeU education benefit

Job summary

Abbott is seeking a Senior Software Design Assurance Engineer to support software quality activities across the product development lifecycle. You will ensure compliance with design controls, oversee verification/validation, and collaborate with R&D and other functional teams.

The role focuses on software quality but also supports broader product development, with opportunities to influence quality systems, risk management, and cybersecurity considerations in a global healthcare environment.

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.

Responsibilities

• Provide technical and quality system guidance for software requirements.
• Oversee software verification and validation activities for new products per design planning procedures.
• Review and approve software test case protocols, reports, and development plans.
• Lead meetings to prioritize action plans for issues identified in problem resolution systems.
• Lead risk evaluation and management activities related to software development, incl. risk analyses.

Skills

Verbal and written communication

Cross-functional collaboration

Quality engineering principles

Education

Bachelor’s degree in engineering or technical field

Advanced degree

Job description

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.

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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.

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.

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 Quality DIVISION: HF Heart Failure LOCATION: United States > Burlington: 23 Fourth Avenue

ADDITIONAL LOCATIONS: United States > Pleasanton : 6101 Stoneridge Dr

WORK SHIFT: Standard TRAVEL: Yes, 5 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT 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.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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

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Abbott is an Equal Opportunity Employer, committed to employee diversity.