Software Design Assurance Engineer

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.

• 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
• Previous quality engineering experience and demonstrated use of quality tools/methodologies.
• Experience working in a broader enterprise/cross-division business unit model., Business Model, Career Development, Code Reviews, Communication Skills, Corporate Policies, Cross-Functional, Diversity, Documentation, Engineering, Establish Priorities, FDA Requirements, Facebook, Failure Mode and Effects Analysis (FMEA), Health Plan, Healthcare, Healthcare Software, International Health, Internet Security, Medical Diagnosis, Medical Equipment, Medical Products, People Management, Preferred Provider Organization (PPO), Presentation/Verbal Skills, Problem Solving Skills, Product Design, Product Development, Product Planning, Product Support, Product Testing, Quality Engineering, Quality Management, Regulations, Regulatory Requirements, Research & Development (R&D), Retirement Plan, Risk Analysis, Risk Management, Software Administration, Software Design, Software Development, Software Engineering, Software Testing, Software Validation, Staff Training, Surveillance, Team Player, Technical Leadership, Technical/Engineering Design, Test Case, Training/Teaching, Tuition

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., 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, At Abbott, we are enthusiastic, energetic and committed to doing great work every day. Our employees are passionate about helping to translate science into lasting contributions to health care and the health of people worldwide. At the heart of our organization is our “Promise for Life”-a statement that embodies our company’s commitment to employees, shareholders, local communities and the people who depend on our company and products to live healthier lives.

Vital to our promise is the speed in which we act, respond and deliver. As Abbott employees, we are ready to meet change and challenges head-on. As a result, we are a company that adapts quickly, and through our passion for innovation we are able to continually create a pipeline of products that help improve the length and quality of life around the world.

We are proud of our rich, more than 120-year history. We continue to be driven to advance leading-edge science and technologies, support diversity, focus on exceptional performance and earn the trust of those we serve.

Company Size: 10,000 employees or more