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Engineering Jobs

Engineer II

Karwell Technologies

  • Irvine, CA
  • 1 day ago

    Highlights

    The role will integrate multiple engineering disciplines to support robust, safe, compliant, and patient-focused product design and performance. Experience developing products within a regulated industry, particularly Medical Device, Pharmaceutical, Biotech, or Combination Product environments.

    Numbers & Facts

    LocationIrvine, CA

    Description

    Job Description:
    • We are seeking a Systems Engineer II to join a Device and Combination Product Development R&D team. The engineer will contribute to the development and launch of innovative drug-device combination products.
    • The role will integrate multiple engineering disciplines to support robust, safe, compliant, and patient-focused product design and performance.
    Responsibilities:
    • Develop and maintain Design History Files (DHF) and Design Control documentation in compliance with applicable regulations.
    • Define User and Stakeholder 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 integration of 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.
    Qualifications:
    • Bachelor's degree: Typically, 5 10 years of relevant experience
    • Master's degree: Typically, 3 7 years of relevant experience
    • PhD: Typically, 1 4 years of relevant experience
    • Strong theoretical and practical understanding of the relevant scientific/engineering discipline.
    • Experience developing products within a regulated industry, particularly Medical Device, Pharmaceutical, Biotech, or Combination Product environments.
    • Experience with Design Controls, DHF, requirements definition, traceability, risk management, and product architecture.
    • Strong written and verbal communication skills.
    • Experience preparing technical, scientific, or regulatory documentation.
    • Demonstrated technical leadership and ability to influence and negotiate internally and externally.
    • Strong analytical, problem-solving, organizational, and decision-making skills.
    • Self-driven, proactive, and comfortable working in a cross-functional/matrixed environment.
    • Regulatory & Industry Standards
    Experience with relevant standards and regulations, including:
    • IEC 60601.
    • ISO 14971.
    • IEC 62304.
    • ISO 11608.
    • ISO 11040.
    • ISO 13485.
    • 21 CFR 820.
    • MDR.
    • FDA/regulatory requirements for medical devices and combination products.
    Top Skills Required:
    • Design Controls experience in Medical Device or Combination Product development.
    • Systems Engineering experience, including Design Inputs and Traceability Matrix.
    • Risk Management experience, including Risk Management Plans, FMEA, and risk assessments.
    • Strong written and verbal communication skills.
    • Experience working in a regulated product-development environment.

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