Staff Software Quality Engineer
4 hours ago
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 MissionWe're committed to helping people live healthier, more fulfilling lives. Our mission is to provide innovative solutions that improve healthcare outcomes and enhance the quality of life for individuals and communities around the world.Job Summary
We're seeking an experienced Staff Software Quality Engineer to join our team in the Abbott Heart Failure Division. As a Staff Software Quality Engineer, you will be responsible for ensuring our medical devices are developed in accordance with Abbott's design control requirements and state of the art standards.
Key Responsibilities- Complete software quality-related tasks and activities for development of medical product software, non-medical software, and non-product software.
- Support software verification and validation activities for new products and software changes in accordance with plans.
- Participate in meetings to evaluate, prioritize, and develop action plans for addressing issues captured in problem resolution systems.
- Perform risk evaluation and associated management activities related to software development.
- Represent the design quality engineering function for review and approval of project deliverables.
- Bachelor's degree in a scientific, technical, or engineering discipline.
- Minimum 8 years of software development and quality engineering experience or an equivalent combination of education and experience.
- Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP.
- Experience using requirements management tools (e.g., DOORS) and using problem reporting systems (e.g., JIRA).
- Hands-on experience with FMEA/risk management.
- Prior experience in a software-focused company or company with software as a medical device (SAMD).
We offer a competitive salary range of $95,000.00 – $190,000.00, depending on location. We also provide a comprehensive benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.
Equal Opportunity EmployerAbbott is an equal opportunity employer and welcomes diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities.
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