Sr Software Design Quality Engineer

About the position

Abbott 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. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Participating in the planning, development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
• Collaboration with On-Market & Development Teams.
• Works closely with software developers, product managers, and other stakeholders to understand technical requirements, provide input on design considerations, and participate in discussions about software functionality.
• Applies basic software knowledge, including understanding of firmware basics, Run time operating systems, Operating systems (Linux, MS Windows, etc.) and application basics (install, running, etc.).
• Applies basic network understanding for the three kinds of networking utilized in our systems (Ethernet, CAN bus, and Near Field Communication (NFC).
• Understands and applies basic Cybersecurity control measures, Familiarity with the Cybersecurity workbook, Threat Modeling, vulnerability assessment and the Cybersecurity Risk Analysis Report.
• Applies basic understanding of SOUP & OTS components and the applicable governing standards.
• Applies basic understanding of the planning, development, modification and maintenance of software.
• Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA's, etc.
• Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
• Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems.
• Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity.
• Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management.
• Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups.

Requirements

• Bachelor's degree in Computer Science, Software Biomedical Engineering; Life Science or closely related discipline is required.
• Minimum 4 years of related work experience in quality or a related field.

Nice-to-haves

• 5+ years' experience covering the entire design control process in a team-oriented environment.
• Prefer tool experience with HP Quality Center, Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS.
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines, 21 CFR Part 11 and IEC 62304 Medical Device Software - Software life cycle processes.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices is a plus.

Benefits

• 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.