Engineer II, Software Development Quality

Job description

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Job Summary:

Software Design Quality Engineer II is responsible for Software Quality relative to the design and development of company products, software reliability, developing and maintaining processes and procedures, and assuring adherence to the software development life cycle across Abbott.  Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.

Job Duties:

• Execute and support on-time completion of Design Control Deliverables
• Support on-time execution of  Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Guides development and documentation of standard operating procedures, specifications and test procedures
• Accountable for Design Verification and Validation planning & execution, including active cross-functional  root-cause analysis investigation & resolution activities
• Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection.
• Reviews test protocols and test results provided by other functional group.   
• Lead or support Risk Management activities from product Concept through Commercialization
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support internal & external audit responses
• Support the establishment of objective, measurable, discrete, and verifiable  customer and product requirements
• Complete Document Change Request Reviews in a timely 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.

Equipment:

May, on occasion, work with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.

Working Conditions:

Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.

Physical Demands:

Activities require a significant amount of sitting in front of a computer monitor, some standing and walking.  Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment.  Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees.

Qualifications:

General Qualifications

• Bachelor level degree in Engineering or Technical Field, advanced degree preferred.
• 3-5 years experience in software testing, development and or validation, including lead or supervisory experience
• Programming knowledge in C/C#/Visual Studio/Java, Scripting Language such as Python, Perl
• Working experience in Web Based and Mobile (iOS, Android) Application
• Programming experience with test automation scripts   
• Previous Software Quality engineering experience and demonstrated use of Quality tools/methodologies
• Experience with software configuration, and issue tracking tools such as GIT, Subversion, ClearQuest, Doors, TortoiseHg, or Bugzilla.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Working knowledge of 21 CFR part 820, IEC 62304, IEC 82304-1, ISO 14971, and ISO 13485
• Ability to work in a highly matrixed and geographically diverse business environment.
• 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.
• Ability to travel 
• Ability to maintain regular and predictable attendance.

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