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Engineer II

Katalyst Healthcares and LifesciencesIrvine, CA🇺🇸United StatesPosted 15 Aug 2026

Why This Role Stands Out

You'll thrive in this hybrid role at Katalyst Healthcares and Lifesciences, contributing to the development of innovative drug-device combination products and gaining valuable experience in a reputable company. This position offers significant growth potential for mid-senior engineers who enjoy cross-functional collaboration and driving impactful projects from concept to launch.

Quick Overview

Work Type
Hybrid
Level
Mid Senior

Job 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.
  • pply 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.

Skills

SAFe

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