Design Assurance Engineer

Title: Design Assurance Engineer Location: Pleasanton, CA 94588 Duration: 7 Months (09/21/2026 to 03/19/2027)Shift: 6AM to 2: 30 PM Description: Subject Matter Expert (SME) is responsible for developing and maintaining quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support.Position Summary:

• A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.
• Interprets regulations and requirements to lead, coach, and mentor teams on Risk Management.
• SME for domestic/international sites and affiliates regarding Risk Management Quality System element.
• Works cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation. Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.
• Perform Health Hazard and Regulatory Risk Evaluations

Essential Functions:

• The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.
• Lead design assurance activities in support of development for risk management files (Hazard Analysis, FMEA, Risk management Planning, Risk Management Report, Benefit Risk Analysis) per ISO 14971 guidelines.
• Manage new risk management file
• Work with Engineering, Marketing, Manufacturing and Regulatory to establish risk management files.
• Understands test plan protocols, test procedures, and test reports used for risk controls.
• Understand design verification and design validation plans and links to the risk management files.
• Understands implication of risk management in Verification and Validation sampling plans.
• Able to lead technical discussions of products and associated risk management documentation.

Education and Requirements:

• Bachelors Degree ( 16 years) Engineering or Technical Field Experience and experience Details Both overall and any industry-specific experience needed: 5 years.
• Experience working in a broader enterprise/cross-division business unit model preferred. Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail. Ability to maintain regular and predictable attendance.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience preferred.
• Experience with risk management (ISO 14971) required.
• Knowledge of various tools and techniques for Risk Management is desirable.
• Knowledge of IEC60601-1 or electrical safety is desirable.