Staff Software Quality Engineer
2 weeks ago
Abbott Laboratories 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.
Job SummaryWe are seeking an experienced Staff Software Quality Engineer to join our team at Abbott Laboratories. 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.
- Support non-product software validation and may be involved with supporting product cybersecurity assessments.
- Work as an individual contributor and provide guidance or oversee work of other Quality Engineering team members.
- Support audits and lead quality system improvement activities.
- Bachelor's degree, or equivalent experience, 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 and problem reporting systems.
- Hands-on experience with FMEA/risk management.
- Prior experience in a software-focused company or company with software as a medical device (SAMD).
- Experience developing or maintaining design controls for software development.
At Abbott Laboratories, 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:
- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
- 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.
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