Design Assurance Engineer
LanceSoft
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:
Essential Functions:
Education and Requirements:
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.
Vacancy posted 3 days ago
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