New · posted Nov 8
Abbott · Medical Devices
Software Quality Engineer I
- Sylmar, CA
- On-site
- Full-time
- Associate & Specialist
The role
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 122,000 colleagues serve people in more than 160 countries.
This is an ONSITE role based out of Sylmar, CA
The Software Quality Engineer I provides design quality engineering support for the development and maintenance of mobile medical device software applications and connected digital health solutions. This role partners closely with software development, systems engineering, cybersecurity, product management, clinical, and regulatory teams to ensure software products are developed in accordance with applicable quality system regulations, industry standards, and company procedures. The position will primarily support native mobile applications (iOS and Android), cloud-connected healthcare solutions, and related software systems.
What you need
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor level degree in Computer science, software engineering or a closely related discipline or an equivalent combination of education and work experience.
- Minimum 2-5+ years of combined experience in software quality, software development, software verification and validation, software testing, or related engineering role.
- Understanding of software development lifecycle methodologies including Agile development practices.
- Fundamental understanding of software engineering principles and quality systems.
- Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl
- Experience with software configuration, and issue tracking tools such as GIT, Jira, Azure DevOps, ClearQuest, DOORS.
- Experience with test automation and analysis tools such as Selenium, Appium, Postman, API testing tools.
- Strong analytical and problem-solving skills.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
Preferred Experiencenice to have
- Experience supporting development and deployment of mobile applications for iOS and Android platforms.
- Experience working in a regulated industry such as medical devices, healthcare, pharmaceuticals, aerospace, or automotive.
- Familiarity with medical device software standards including: IEC 62304, ISO 14971, IEC 62366, IEC 82304-1, FDA Quality System requirements
- Knowledge of mobile application architecture and development concepts.
- Experience reviewing software requirements, test protocols, and design documentation.
- Familiarity with software defect tracking and requirements management tools.
- Experience with cloud-connected, distributed, or client-server software systems.
- Understanding of cybersecurity principles and secure software development practices.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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.
Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
What you'll do
- Support design quality activities throughout the software development lifecycle, including requirements reviews, risk management, software verification and validation, traceability assessment, cybersecurity assessments and defect management.
- Review software lifecycle deliverables, participate in design and release reviews, and ensure software development activities align with Design Control requirements, software lifecycle standards, and risk management processes.
- Support software risk management activities in accordance with ISO 14971 and internal procedures.
- Evaluate software defects and assess potential product quality impacts.
- Participate in investigation and resolution of software-related quality issues.
- Gain familiarity with testing methodology, processes, tools, templates, environment, and work with cross functional teams to complete tasks assigned
- Review system, integration, regression, usability, and mobile application testing verification strategies, protocols, reports, and test evidence. Review test coverage to ensure adequate verification of requirements and risk controls.
- Complete Document Change Request Reviews in a timely and objective manner
- Drive continuous improvement activities and support investigations, CAPAs, and compliance initiatives related to software products and processes.
- Support preparation and maintenance of Design History File (DHF) and software lifecycle documentation.
- Support internal & external audit and related responses
- Additional duties may be identified by functional management based on the current project/business objectives.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Pay and benefits
$73,900 – $116,000 a year
Employer providedThe base pay for this position is
$73,900.00 – $116,000.00
In specific locations, the pay range may vary from the range posted.
Free medical coverage through Health Investment Plan (HIP) PPO
Retirement savings plan with high employer contribution
Tuition reimbursement
Freedom 2 Save student debt program
FreeU education benefit
Career development
Where you'll work
Sylmar, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Sylmar, CAWorking conditions
Standard
TRAVEL
Yes, 10 % of the Time
MEDICAL SURVEILLANCE
Not Applicable
JOB FAMILY
Operations Quality
DIVISION
CRM Cardiac Rhythm Management
LOCATION
United States > Sylmar : 13150 Telfair Avenue
From the posting
About Abbott
WORKING AT ABBOTT
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
Equal opportunity, accessibility and legal noticesAbbott's statements, word for word
Abbott is an Equal Opportunity Employer, committed to employee diversity.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)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
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Software Quality & CSV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $73,900 | — | $116,000 |
| All US (middle half) | $84,000 | $94,000 | $108,875 |
This role: Abbott's own published range. Comparisons: the base pay employers published on open Software Quality & CSV roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Software Quality & CSV
The general path across 56 open Software Quality & CSV roles on Regulatory Jobs, with the titles they carry most. Not Abbott's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems18
- Quality systems and risk8
- Lab testing and methods7
- Documentation and SOPs7
- Collaboration and leadership6
- GMP and compliance4
- Investigations and CAPA2
- Validation and qualification2
- Clinical trial conduct2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Software Quality & CSV work in medical devices, led by the four this posting names, each linked to the agency or standards body that publishes it.
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device softwareNamed in the posting
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devicesNamed in the posting
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devicesNamed in the posting
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
Company hiring pulse
Abbott on Regulatory Jobs
- 111
- Open roles
- 111
- Distinct roles
- 34
- Locations
By discipline
- Quality59 53%
- Regulatory30 27%
- Clinical22 20%
By level
- Senior & Principal53 47%
- Associate & Specialist32 29%
- Manager24 21%
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Software Quality Engineer I at Abbott
Open until filled. $74K–$116K a year, employer provided.