Design Assurance Engineer

Intellectt Inc; California (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Intellectt Inc in Pleasanton, CA is seeking a Design Assurance Engineer / Risk Management SME to lead and maintain ISO 14971-based risk management activities within a GMP/ISO-compliant quality system across the product lifecycle.

You will collaborate with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing to develop Risk Management Plans, DFMEA, Hazard Analyses, and Risk Reports, ensuring appropriate risk controls and documentation throughout development and production.

Qualifications

• Bachelor’s degree in Engineering or related field required.
• 5+ years of relevant engineering/quality experience in medical devices.
• Strong knowledge of ISO 14971 and risk management files.
• Understanding of DV/VPV (DV/V&V) and their link to risk management.
• Experience with GMP/ISO-compliant quality systems.

Responsibilities

• Lead risk management activities for new product development and sustaining engineering.
• Develop and maintain ISO 14971-based risk management files and related documents.
• Establish, evaluate, and maintain product risk controls and documentation.
• Collaborate with cross-functional teams to identify and assess product risks.
• Review DV/DV plans and ensure linkage to risk management documentation.
• Evaluate test protocols and reports to support risk controls.
• Lead technical discussions on product risks, hazards, and compliance.
• Provide coaching on risk management practices to teams.

Skills

ISO 14971 Risk Management

FMEA & Hazard Analysis

Risk Management Files

DV / V&V linkage

GMP/ISO quality systems

Cross-functional collaboration

Documentation & reporting

Electrical safety knowledge

Education

Bachelor’s degree in Engineering or related field

Job description

Job Title: Design Assurance Engineer – Risk Management

Location: Pleasanton, CA

Duration: Long-term

Job Summary

Seeking a Design Assurance Engineer / Risk Management SME to lead and maintain medical device risk management activities within a GMP/ISO-compliant quality system. The engineer will partner with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to develop and maintain ISO 14971-compliant risk management files, ensuring risks are appropriately identified, controlled, verified, and documented throughout the product lifecycle.

Key Responsibilities

• Lead risk management activities for new product development and sustaining engineering.
• Develop and maintain Risk Management Plans, Hazard Analyses, FMEAs, Risk Management Reports, and Benefit-Risk Assessments in accordance with ISO 14971.
• Establish, evaluate, and maintain product risk controls and associated documentation.
• Partner with Engineering, Manufacturing, Quality, Regulatory, Clinical, and Marketing teams to identify and assess product risks.
• Review Design Verification and Design Validation (DV/DV) plans and ensure appropriate linkage to risk management documentation.
• Evaluate test protocols, procedures, and reports supporting implementation and effectiveness of risk controls.
• Assess the impact of risk management requirements on V&V sampling plans.
• Lead technical discussions related to product risks, hazards, risk controls, and compliance documentation.
• Provide coaching, mentoring, and training to product development and sustaining engineering teams on risk management practices.
• Perform Health Hazard Evaluations and Regulatory Risk Evaluations.
• Interpret applicable regulations and quality requirements and provide guidance to cross-functional teams.
• Support continuous improvement and effectiveness of the Risk Management Quality System across sites and affiliates.

Skills & Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 5+ years of relevant engineering/quality experience, preferably within the medical device industry.
• Strong hands-on experience with ISO 14971 Risk Management.
• Experience developing and maintaining medical device Risk Management Files.
• Strong knowledge of FMEA, Hazard Analysis, Risk Controls, Benefit-Risk Analysis, and Risk Management Reports.
• Understanding of Design Verification and Design Validation and their relationship to risk management.
• Experience reviewing test plans, protocols, procedures, and reports supporting risk controls.
• Knowledge of GMP/ISO-compliant quality systems.
• Strong technical, analytical, documentation, and report-writing skills.
• Ability to lead cross-functional technical discussions and influence teams without direct authority.
• Strong communication, organizational, prioritization, and problem-solving skills.
• Ability to work effectively in a matrixed, geographically diverse environment.
• Advanced computer and data-analysis skills.
• IEC 60601-1 and electrical safety knowledge preferred.