Job Description
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.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $90 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Business Modelunmatched
- Coachingunmatched
- Communication Skillsunmatched
- Compensation and Benefitsunmatched
- Computer Skillsunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Design Verificationunmatched
- Detail Orientedunmatched
- Documentationunmatched
- Electricityunmatched
- Establish Prioritiesunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Follow Throughunmatched
- GMP (Good Manufacturing Practices)unmatched
- Hazard Analysisunmatched
- ISO (International Organization for Standardization)unmatched
- International Electro-Technical Commission (IEC)unmatched
- Interpret Regulationsunmatched
- Leadershipunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Requirementsunmatched
- Manufacturing Systemsunmatched
- Marketingunmatched
- Medical Equipmentunmatched
- Medical Productsunmatched
- Mentoringunmatched
- Multitaskingunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Product Developmentunmatched
- Product Documentationunmatched
- Product Supportunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Reporting Skillsunmatched
- Riskunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Statisticsunmatched
- Systems Maintenanceunmatched
- Technical Leadershipunmatched
- Technical/Engineering Designunmatched
- Test Plan/Scheduleunmatched
- Testingunmatched
- Time Managementunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
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