Engineer IV (Medical Device)

Title: Engineer IV - (Medical Device)

Location: Pleasanton, CA

Duration: 6 Months

100% Onsite

Qualifications:

• Experience working in regulated product development environments (medical devices strongly preferred, aerospace, automotive, or similar also acceptable)
• Working knowledge of design control, configuration management, defect tracking, and change management processes
• Demonstrated experience collaborating with internal stakeholders to understand business objectives and high-level product requirements, then convert them into detailed software requirements, functional specifications, and interface definitions.

Responsibilities:

• Collaborate with cross-functional stakeholders (clinical, regulatory, engineering, and commercial teams) to define product vision, business objectives, and high- level requirements for cloud and mobile solutions supporting heart failure management.
• Own end-to-end requirements definition, translating user needs and intended use into detailed software/system requirements, functional specifications, and interface definitions that are testable, traceable, and compliant with regulatory standards (e.g., FDA, IEC 62304).
• Lead and facilitate design and technical reviews, ensuring alignment with system architecture, requirements integrity, risk controls, and compliance with quality system processes and design controls.
• Partner closely with Systems Engineering, Software Development, and Verification/Validation teams to ensure requirements are clear, decomposed, allocatable, testable, and integrable across subsystems.
• Contribute to risk management activities, including hazard analysis, FMEA, and risk assessments (ISO 14971); ensure risk mitigations are properly captured in requirements, design, and verification plans.
• Actively participate in cross-functional and leadership reviews, providing clear visibility into product progress, system performance, risks, and compliance status.
• Foster strong collaboration and communication across all levels of the organization, including internal teams, customers, vendors, and external partners.
• Develop and apply an expert understanding of designated systems as well as serve as a subject matter expert to solve problems and deliver upon business objectives.
• Communicate integration risks, technical tradeoffs, and system impacts and ensure compliance with applicable quality system requirements.

Education:

• Bachelor’s degree in Systems Engineering, Biomedical Engineering, Software Engineering, Computer Science, or a related technical field with 5-6 years of relevant experience, OR
• Master’s degree in a related technical field with a minimum of 4 years of relevant experience.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.