Staff Engineer, Software Design Assurance (Medical Device)

Abbott Laboratories • Pleasanton, CA

78d • $112,000 - $224,000

About The Position

This position works onsite out of our Pleasanton, CA or Burlington, MA location in the Abbott Heart Failure Division Global Design Quality Department. In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives. We are seeking an experienced Staff Engineer, Software Design Quality to ensure our medical devices are developed in accordance with Abbott's design control requirements and state of the art standards. The Staff Engineer, Software Design Quality will serve as a technical representative providing quality oversight for Software Development projects. The Staff Engineer, Software Design Quality is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.

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.

Nice To Haves

• 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.

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.

Benefits

• Career development with an international company.
• 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.
• Recognized as a great place to work in dozens of countries.
• Named one of the most admired companies in the world by Fortune.
• Best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree