Senior Software Design Assurance Engineer

Abbott

Senior Software Design Assurance Engineer ensuring software quality while supporting product development at Abbott. Responsibilities include software verification, quality oversight, and compliance with regulations.

Posted 6/4/2026full-timeCalifornia, Massachusetts • 🇺🇸 United StatesSenior💰 $78,000 - $156,000 per yearWebsite

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

software requirementssoftware verificationsoftware validationrisk assessmentFMEAquality toolsquality methodologiesdesign planningproduct cybersecurity assessmentstraining development

Soft Skills

communicationcollaborationleadershipproblem resolutionoversightguidanceprioritizationreviewapprovalindividual contributor

Certifications

Bachelor’s degreeAdvanced degree