Hybrid Staff Engineer, Software Design Assurance – Medical Device

at Abbott

• Job title: Staff Engineer, Software Design Assurance – Medical Device
• Job type: Full Time
• Experience level: Lead
• Salary: $112,000 - $224,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: Cloud, Cyber Security
• Location requirements: Hybrid, Pleasanton, United States

About the role

• Staff Engineer ensuring Abbott's medical devices meet rigorous software quality standards. Responsible for oversight of software development in accordance with design control requirements and regulatory standards.

Responsibilities

• Provide oversight of R&D design control deliverables for development of medical product software (Cloud Patient Care Networks, mobile applications and embedded software), non-medical software, and non-product software.
• Support software verification and validation activities for new products and software changes in accordance with plans.
• Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.
• Participate in meetings to evaluate, prioritize, and develop action plans for addressing software defects/bugs captured in the problem resolution systems.
• Perform risk assessments and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
• Participate in technical and management reviews to ensure design plans, product designs, and deliverables related to product software are met.
• Represent the Global Design Quality Department for final review and approval of project deliverables.
• Support 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.
• Work as an individual contributor and provide guidance or oversee work of other Software Quality team members.
• Support audits and lead quality system improvement activities.
• Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures.

Requirements

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Minimum 8 years of Software Development and Design 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 with medical device software development lifecycle for Cloud-based networks and/or mobile applications.
• Experience using requirements management tools (e.g., DOORS) and using problem reporting systems (e.g., JIRA).
• Hands-on experience with FMEA/risk management.
• Experience developing or maintaining design controls for software development.

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.