Software Development Quality Engineer II

Thornton Tomasetti; California; Hybrid; USD 82,000 - 141,000; Full time

Job summary

Abbott is seeking an onsite Software Development Quality Engineer II in Sylmar, CA to drive quality for firmware and software across the product lifecycle. You will develop, execute and automate test plans, collaborate with cross-functional teams, and help maintain regulatory compliance of DHF artifacts.

The role emphasizes design verification and validation, risk management, and process improvements with a focus on patient safety and product quality.

Qualifications

• 2+ years of software development and/or embedded systems experience.
• 2–5+ years of software testing and verification/validation.
• Proficient in C, C++, C#, Python, Java or Visual Studio.
• Experience with Git, Jira, Subversion, ClearQuest, DOORS or Bugzilla.
• Experience with static analysis tools and code review practices.
• Experience in Agile or iterative SDLC programs.
• Knowledge of FDA/ISO quality contexts is a plus.

Responsibilities

• Plan, execute, and complete quality engineering deliverables on schedule (manual and automated).
• Lead test planning and execution with cross-functional teams.
• Develop SOPs, specs, and test procedures per Quality System requirements.
• Perform DVP/IVD style V&V activities and test automation as appropriate.
• Review test protocols and results for accuracy and compliance.
• Support risk management, audits, and regulatory responses.
• Drive continuous improvement of testing lifecycles with tools and best practices.

Skills

C

C++

C#

Python

Java

Visual Studio

Git

Jira

Subversion

ClearQuest

DOORS

Bugzilla

Code Collaborator

Coverity

Parasoft DTP

Agile SDLC

Education

Bachelor's Degree in Engineering or Technical Field

Tools

Automation test tools

Job description

## Software Development Quality Engineer IIApplylocations: United States - California - Sylmartime type: Full timeposted on: Posted Yesterdayjob requisition id: 31158965Abbott 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:**Job DescriptionAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.**Working at Abbott**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.## ## ## ***MAIN PURPOSE OF THE ROLE**** This role is **ONSITE** and is based out of the **Sylmar, CA** location.* This position is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout division.## ***MAIN RESPONSIBILITIES***We are seeking a high‐caliber **Software Development Quality Engineer** to support the design and development of new products, with a primary focus on firmware and communication software, as well as non‐product software, including automated manufacturing test systems. This role contributes to ensuring software reliability, developing and maintaining quality processes and procedures, and assuring adherence to the software development lifecycle across Abbott. The successful candidate will build strong, collaborative partnerships with cross‐functional teams to support organizationalsuccess while protecting patient and user safety and meeting business needs.## ***What You’ll Do**** Plan, execute, and complete Quality Engineering deliverables on schedule, including manual and automated test plans, test procedures, scripts, and reports.* Lead and coordinate test planning and execution activities, ensuring alignment with project schedules and cross‐functional dependencies.* Acquire and apply a strong understanding of testing methodologies, processes, tools, templates, and test environments to effectively support assigned projects.* Clearly communicate and support team members and cross‐functional partners in understanding testing strategies, processes, tools, and quality concepts.* Develop, review, and maintain standard operating procedures (SOPs), specifications, and test procedures in accordance with Quality System requirements.* Execute Design Verification and Validation (V&V) activities, including hands‐on testing, test automation development as appropriate, and cross‐functional root‐cause analysis and issue resolution.* Participate in and provide quality input during system, software, and firmware requirements reviews, design reviews, and code inspections, leveraging static analysis and test‐driven development (TDD) practices as applicable.* Review and assess test protocols, procedures, and test results generated by other functional groups to ensure accuracy, completeness, and compliance.* Support product Risk Management activities, including identification, assessment, and verification of software‐related risk controls.* Proactively identify opportunities to improve software and firmware design reviews through enhanced quality tools, checklists, and review practices.* Drive continuous improvement of the software and firmware testing lifecycle through the introduction and adoption of effective tools, automation, and best practices.* Ensure Design History File (DHF) content is complete, accurate, traceable, and compliant with applicable regulatory and standards requirements, and collaborate to resolve gaps.* Support internal and external audits, inspections, and associated responses, including preparation and resolution of observations.* Support the definition and verification of objective, measurable, and verifiable customer and product requirements.* Review and approve Document Change Requests in a timely, thorough, and objective manner.* 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.***QUALIFICATIONS******Education***Bachelors Degree (± 16 years) in an Engineering or Technical Field (OR) an equivalent combination of education and work experience.***Experience/Background**** Minimum 2 years* 2–5+ years of combined experience in software development and/or embedded systems applications.* 2–5+ years of combined experience in software testing and verification/validation.* Programming experience in one or more of the following languages or environments: C, C++, C#, Python, Java, Visual Studio, etc.* Experience using software configuration management and defect tracking tools such as Git, Jira, Subversion, ClearQuest, DOORS, Bugzilla, or equivalent.* Experience with code review and static analysis tools (e.g., Code Collaborator, Coverity, Parasoft DTP) to support software and firmware quality assessments.* Experience working as a team member in Agile or iterative software development lifecycle (SDLC) programs.* Working knowledge of multiple software and test lifecycles, including V‐Model, Iterative, and Agile/Scrum methodologies.* Experience supporting automated test execution and coordination.* Ability to work effectively in a highly matrixed and geographically diverse environment.* Ability to contribute both as an individual contributor and as an effective team member in a fast‐paced, changing environment.* Demonstrated ability to influence and collaborate with cross‐functional partners to accomplish project objectives.* Strong verbal and written communication skills, with the ability to communicate effectively at multiple levels within the organization.* Proven ability to prioritize, multitask, and meet deadlines in a dynamic work environment.* Strong organizational, follow‐up, and attention‐to‐detail skills.* Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485. Advanced computer skills, including statistical/data analysis and report writing. Advanced Information Technology and data mining skills.* Prior medical device experience preferred. ASQ CSQE certification desired.* Experience working in a broader enterprise/cross-division business unit model preferred.* Ability to leverage and/or engage others to accomplish projects.**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.comFollow 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 and @AbbottGlobal.**The base pay for this position is**$81,500.00 – $141,300.00In specific locations, the pay range may vary from the range posted.## **JOB FAMILY:**Operations Quality## **DIVISION:**CRM Cardiac Rhythm Management## **LOCATION:**United States > Sylmar : 15900 Valley View Court## **ADDITIONAL LOCATIONS:**## **WORK SHIFT:**Standard## **TRAVEL:**Yes, 5 % of the Time## **MEDICAL SURVEILLANCE:**Not Applicable## **SIGNIFICANT WORK ACTIVITIES:**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