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 109,000 colleagues serve people in more than 160 countries.

Senior Software Verification Engineer – Heart Failure Therapy Burlington, MA

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure (HF) division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies. As a global leader in Mechanical Circulatory and Cardiac Pressure Measurement Systems, our breakthrough medical device technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart failure (HF).

As a Senior Software Verification Engineer, you will be responsible for accessing the validation needs of Off-the-self (OTS) and custom developed non product software and creating the test protocols, reports and supporting documentation to comply with Abbott’s SOPs and applicable regulations.

Duties and Responsibilities:

• Build, track and manage inventory of all OTS and non-product software used in software development and verification.

• Assess the need for validation of Off-the-shelf (OTS) software and create risk assessment documentation, supporting protocols, reports and other documentation.

• Analyze requirements, develop test protocols, document reports to validate custom non-product software applications developed in house.

• Provide technical and process leadership to project teams on verification & validation of non-product software.

• Be an advocate for reuse of non-product software applications where possible, to improve compliance to process and efficiency of non-product software validation.

• Work with managers to bring up the resourcing needs necessary to complete deliverables in line with the project milestones.

• Work with vendors, external partners to supporting non-product software validation. Lead reviews to ensure all deliverables meet Abbott’s SOPs and quality standards

• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. 

• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Experience and Education Requirements:

• Bachelor’s Degree in Engineering (Computer, Electrical, or Software), Computer Science, or related discipline.

• 6+ years of experience in software verification and validation in Medical Device or Pharmaceutical industry.

• Strong experience in accessing validation needs and creating supporting document for SOUP and Off-the-Shelf (OTS) software such as open source libraries and packages, IDEs, Compilers, test automation frameworks, script interpreters etc.

• Strong experience in developing, reviewing requirements, creating test protocols, and test summary reports for custom developed desktop and embedded software applications.

• Good knowledge in testing of software packages and applications developed in C/C++, Python and similar languages.

• Working knowledge of the FDA 21 CFR Part 11, General Principles of Software Validation.

• Strong verbal and written communication with ability to effectively communicate at multiple levels in the organization.

• Multitasks, prioritizes and meets deadlines in timely, proactive manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Perform other related duties and responsibilities, as assigned.

Preferred Qualifications / Education

• Ability to work in geographically distributed teams.

• Ability to leverage and/or engage vendors, external partners to accomplish projects.

• Knowledge in communication protocols such as Serial, Ethernet, BLE.

• Experience with accessing risks and validation needs of non-product software for cybersecurity and data integrity aspects is a plus.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

• Training and career development, with onboarding programs for new employees and tuition assistance  

• Financial security through competitive compensation, incentives and retirement plans  

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 

• Paid time off  

• 401(k) retirement savings with a generous company match 

• The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.