Software Design Quality Engineer

Abbott; United States; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Free medical coverage in HIP PPO

Excellent retirement contribution

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is hiring a Software Design Quality Engineer for the Westford, MA site in a fully onsite role. You will lead quality deliverables across the product lifecycle, emphasizing cybersecurity design quality and adherence to design controls.

Bring 2–5+ years in software design quality, experience with automation and Agile testing, and a passion for medical device software quality and risk management.

Qualifications

• Bachelor-level degree in a related field or equivalent experience.
• 2–5+ years of software design quality and cybersecurity design quality.
• Experience ensuring automation frameworks and scripts meet design control requirements.
• Experience with software configuration management.

Responsibilities

• Lead, execute and support on-time quality deliverables from concept to commercialization.
• Support on-time execution of Quality Plans and risk management activities.
• Guide SOPs, specifications and test procedures development.
• Collaborate in reviews of system/software requirements and code inspections.
• Support software change management and lifecycle quality initiatives.

Skills

Quality Engineering

Cybersecurity Quality

Agile testing

Automation testing

Education

Bachelor's degree in Computer Science / Biomedical Engineering / Software Engineering

Tools

Automation scripts

Job description

JOB DESCRIPTION:

Job Title

Software Design Quality Engineer

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:

• 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.

THE OPPORTUNITY

We currently have an opening for a Software Design Quality Engineer for the Vascular division; this role is located at our Westford, MA location and is a fully onsite role.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

MAIN RESPONSIBILITIES

• Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
• Support on-time execution of Quality Plans
• Guide development and documentation of standard operating procedures, specifications and test procedures
• Support product recertifications
• CAPA management - including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
• Work within Agile software development lifecycle framework
• Support usability and human factors engineering reviews
• Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
• Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
• Review and approve test methods, protocols and test results provided by another functional group.
• Support activities related to software change management and overall change management
• Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
• Support all activities, as needed by the business within the software development lifecycle.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support internal & external audit and related responses
• Support the establishment of objective, measurable 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.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE YOU'LL BRING

REQUIRED EXPERIENCE

• Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
• Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
• Experience ensuring automation frameworks and scripts meet design control requirements
• Experience with software configuration, a