At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The Staff Software Quality Engineer is responsible for supporting product development of mechanical circulatory support systems for patients with heart failure. Products include pumping systems, electronic controllers, power sources, and other devices for temporary and long-term management of heart failure. The Staff Software Quality Engineer position focuses primarily on software quality, but also supports other aspects of product development based on experience.
The Staff Software Quality Engineer position:
- Provides technical and quality system guidance related to establishing software requirements.
- Supports software verification and validation activities for new products in accordance with design planning procedures. This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
- Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
- Performs risk evaluation and associated management activities related to software development including 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.
- Supports 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
- Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
- 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 work of other QE team members.
- Bachelor level degree in Engineering or Technical Field;
- 8+ years of software engineering experience
- Previous quality engineering experience and demonstrated use of quality tools/methodologies
- Experience working in a broader enterprise/cross-division business unit model preferred
- advanced degree preferred
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Knowledge of regulations and standards affecting software development and overall design control for medical devices.