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Functional Safety Engineer (IEC 62304, Functional safety engineering)

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StageNot listed in company directoryStandardsIEC 62304 · ISO 14971 · IEC 60601IndustryMedicalSeniorityMid-levelRegionLos Angeles Metropolitan AreaWork modeOnsiteSource year2026Role familyFunctional safety engineeringEmploymentFull-timeEmployerNot in the directory
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Role summary

As an Engineer at the organization, you will build the safety basis for a new NRC-licensed enrichment facility under 10 CFR Part 70. You will not inherit a 20-year-old ISA Summary and run change packages. You will develop the hazard analyses, accident sequences, and IROFS from the ground up, and your conclusions will shape the design while it is still on the drawing board. You will work directly with process, controls, and operations engineers, and you will be a technical voice in our NRC interactions. This is a mission of national importance, and few engineers get to take a Part 70 safety basis from a blank page through license application and into operation.

Responsibilities

  • Own and develop Integrated Safety Analyses per 10 CFR Part 70 Subpart H and NUREG-1520, including hazard identification, accident sequence development, consequence analysis, and likelihood evaluation.
  • Lead process hazard analyses (HAZOP, What-If, ) with design and operations teams, and drive the resulting actions to closure.
  • Define, evaluate, and maintain IROFS and management measures, and work with designers to favor inherently safer process choices over layered administrative controls.
  • Develop and maintain the Summary, safety basis change packages, and supporting technical analyses for the license application.
  • Assess risks across nuclear criticality safety, chemical hazards (including UF6 and process chemicals), fire protection, and natural phenomena and external hazards.
  • Support NRC interactions, including audits, inspections, and responses to requests for additional information.
  • Participate in design verification, configuration management, and change control for modifications that affect the safety basis.
  • Support startup, commissioning, and operational readiness as the facility moves from design to operation.

Requirements

  • Bachelor’s degree in Chemical, Mechanical, or Nuclear Engineering, or a related field. An MS, MBA, or PhD may substitute for 2–3 years of experience, depending on degree level.
  • 4+ years of experience in nuclear safety, process safety, or similar high-hazard environments.
  • Working knowledge of safety analysis methods such as PHA, Criticality Safety Analysis, Fire , and External Hazard Analysis.
  • Evidence of exceptional ability (prior projects, portfolio of work, completed products, etc.).
  • Strong analytical skills and attention to detail, and the ability to explain technical safety conclusions clearly, in writing and in person, to engineers, operators, and regulators.
  • Ability to work collaboratively across engineering, operations, and licensing teams.
  • Ability to work extended hours and weekends as necessary.

Nice to have

  • 8+ years of experience in nuclear safety, process safety, or similar high-hazard environments.
  • Direct experience with , ISA Summaries, IROFS, SARs, and risk determination at a Part 70 facility, or with DSA/SAR work under DOE 10 CFR 830.
  • Experience with an NRC Part 70 license application or RAI responses.
  • Petrochemical or PSM experience (HAZOP, LOPA, ). This is a strong substitute for nuclear experience, and we know the methods transfer.
  • Knowledge of UF6 hazards, vacuum systems, cryogenics, compressible flow, or nuclear chemical processes.
  • Experience in a fast-paced, resource-constrained environment where a resourceful, entrepreneurial approach was required to meet tight timelines.
  • Familiarity with NRC safety standards and the associated regulatory framework.

Standards

  • IEC 62304 Medical Device Software - Software Life Cycle Processes
  • ISO 14971 Medical Devices - Application of Risk Management
  • IEC 60601 Medical Electrical Equipment - Basic Safety and Essential Performance

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