Engineer, Design Assurance

Abbott; Pleasanton (CA); On-site; USD 120,000 - 150,000; Part time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account (HSA)

Flexible Spending Accounts (FSA)

Short Term Disability

Long Term Disability

401(k)

Job summary

Abbott in Pleasanton, CA is seeking a Design Assurance Engineer for a 6-month on-site assignment to implement and maintain Risk Management processes within the Quality System. The role partners with engineering, manufacturing, regulatory, and clinical teams to ensure comprehensive risk assessments and compliance.

The successful candidate will lead risk-management activities, develop hazard analyses, and mentor teams on best practices while supporting design verification and validation activities

Qualifications

• Minimum 5 years of experience in Design Assurance, Quality Engineering, or Risk Management.
• Strong knowledge of ISO 14971 and medical device risk management.
• Experience working in a cross-functional and matrixed environment.
• Excellent communication, analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines.
• Advanced data analysis and report-writing skills.

Responsibilities

• Lead Risk Management activities and documentation in accordance with ISO 14971.
• Develop and maintain Hazard Analysis, FMEA, Risk Management Plans, Risk Management Reports, and Benefit-Risk Analyses.
• Manage new and existing Risk Management Files.
• Work with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing teams on product risk assessments.
• Support design verification and validation activities related to risk controls.
• Review test plans, protocols, procedures, and reports supporting risk mitigation.
• Perform Health Hazard Evaluations and Regulatory Risk Evaluations.
• Lead technical discussions related to product risks and risk documentation.
• Mentor and train teams on Risk Management requirements and best practices.

Skills

ISO 14971 knowledge

Risk Management

Quality engineering

Cross-functional collaboration

Communication and problem-solving

Education

Bachelor's Degree in Engineering or Technical Field

Job description

Title: Design Assurance Engineer

Location: Pleasanton, CA

Duration: 6 Month

Shift: 6AM - 2:30PM

100% On-Site

Position Summary

• Responsible for implementing and maintaining Risk Management processes within the Quality System.
• Provide quality engineering support for new product development, manufacturing, and post-market activities.
• Serve as the SME for Risk Management and ensure compliance with GMP, ISO, and regulatory requirements.
• Collaborate with cross-functional teams to establish and maintain product risk documentation.

Key Responsibilities

• Lead Risk Management activities and documentation in accordance with ISO 14971.
• Develop and maintain Hazard Analysis, FMEA, Risk Management Plans, Risk Management Reports, and Benefit-Risk Analyses.
• Manage new and existing Risk Management Files.
• Work with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing teams on product risk assessments.
• Support design verification and validation activities related to risk controls.
• Review test plans, protocols, procedures, and reports supporting risk mitigation.
• Perform Health Hazard Evaluations and Regulatory Risk Evaluations.
• Lead technical discussions related to product risks and risk documentation.
• Mentor and train teams on Risk Management requirements and best practices.

Required Skills & Experience

• Minimum 5 years of experience in Design Assurance, Quality Engineering, or Risk Management.
• Strong knowledge of ISO 14971 and medical device risk management principles.
• Experience working in a cross-functional and matrixed environment.
• Strong communication, analytical, organizational, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines.
• Advanced computer, data analysis, and report-writing skills.

Education:

• Bachelor's Degree in Engineering or Technical Field

Preferred Qualifications

• Medical device industry experience.
• Knowledge of Risk Management tools and methodologies.
• Knowledge of IEC 60601-1 and electrical safety requirements.

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.