Abbott Senior Software Quality Engineer in Pleasanton, California
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.
The Senior Software Operations Quality Engineer is responsible for supporting the manufacturing operations in Pleasanton for the 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 Senior Software Quality Engineer position focuses primarily on software quality, but also supports other aspects of product development based on experience.
The Senior Software Operations Quality Engineer position:
Provides technical and quality system guidance related to establishing software requirements.
Supports software verification and validation activities for upgrades to commercially approved products in accordance with software 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.
Subject Matter Expert in blue tooth and software applications
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 manufacturing operations.
Works as an individual contributor and may provide guidance to other Quality Engineers or cross functional team members.
Bachelor level degree in Engineering or Technical Field
6+ years of industry experience
Previous quality engineering experience and demonstrated use of quality tools/methodologies
Knowledge of regulations and standards affecting software used in medical devices.
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.
Verification & Validation
U.S. Food & Drug Administration Regulations
Ability to Effectively Communicate
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com