Senior Systems Engineer - Medical Device & Drug-Device

Katalyst-Healthcares-; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

JobDiva, Inc. is seeking a Systems Engineer II to join our Device and Combination Product Development – R&D team in Irvine, CA.

The engineer will contribute to development and launch of innovative drug-device combination products, integrating multiple disciplines to ensure robust, safe, compliant, patient-focused design. The role emphasizes design controls, requirements traceability, risk management, and cross-functional collaboration to meet regulatory standards and project timelines in a

Qualifications

• Experience with Design Controls, DHF, and requirements traceability.
• Regulatory knowledge in medical devices or combination products.
• Strong written and verbal communication skills.
• Ability to influence stakeholders in a matrix organization.

Responsibilities

• Develop and maintain DHF and Design Control documentation.
• Define User Needs and perform Use Case Analysis.
• Develop and maintain Design Inputs, System/Sub-System Requirements, and requirements traceability.
• Perform Standards Coverage Analysis.
• Support System Architecture and System Integration activities.
• Integrate third-party development activities into the overall product development process.
• Develop and support Risk Management Plans, risk assessments, and risk reporting.
• Conduct or support FMEA and Use Error Risk Assessments.
• Support drug product development activities.
• Support design verification and validation activities.
• Collaborate across engineering and cross-functional teams to meet project objectives.
• Provide technical leadership and influence stakeholders within a matrixed organization.
• Support implementation and improvement of Systems Engineering principles.
• Ensure system design and documentation meet applicable safety, quality, and regulatory requirements.
• Identify project risks and develop appropriate mitigation strategies.
• Support project schedules, priorities, and competing deliverables.
• Apply strong analytical and decision-making skills to resolve technical challenges.

Skills

Design Controls

Systems Engineering

Risk Management

Regulatory Knowledge

Technical Leadership

Cross-functional Collaboration

Analytical Thinking

Written Communication

Education

Bachelor's degree

Master's degree

PhD

Job description

JobDiva, Inc. is seeking a Systems Engineer II to join our Device and Combination Product Development – R&D team in Irvine, CA.

The engineer will contribute to development and launch of innovative drug-device combination products, integrating multiple disciplines to ensure robust, safe, compliant, patient-focused design. The role emphasizes design controls, requirements traceability, risk management, and cross-functional collaboration to meet regulatory standards and project timelines in a