Key Responsibilities and Required Skills for Safety Engineering and Assurance Specialist

🎯 Role Definition

The Safety Engineering and Assurance Specialist is a subject-matter expert accountable for defining, implementing, and verifying safety and assurance activities across complex systems and products. This role leads hazard analyses, develops and maintains safety cases and certification artifacts, drives compliance with applicable industry standards and regulations, and partners with engineering, quality, and program teams to reduce safety risk from concept through decommissioning. Ideal candidates combine deep technical experience (system/software/hardware safety), process discipline, and proven experience supporting certification and regulatory engagement.

📈 Career Progression

Typical Career Path

Entry Point From:

Systems Engineer with safety exposure
Reliability or Quality Engineer
Aerospace/Automotive/Medical Device Engineer with safety project experience

Advancement To:

Lead Safety Engineer / Principal Safety Engineer
Safety Assurance Manager or Certification Manager
Head of Safety / Director of Safety & Compliance
Chief Systems Engineer or VP of Engineering (safety-focused)

Lateral Moves:

Systems Engineering (MBSE)
Product Safety & Compliance
Reliability Engineering / Failure Analysis
Regulatory Affairs & Certification

Core Responsibilities

Primary Functions

Lead and execute system safety analyses across the product lifecycle, including hazard identification and classification, functional hazard assessment (FHA), fault tree analysis (FTA), failure mode and effects analysis (FMEA), and system-theoretic process analysis (STPA), ensuring traceability from hazards to mitigations and verification.
Develop, maintain and present comprehensive safety cases and safety argumentation packages that demonstrate compliance to internal safety policies and external regulatory requirements for certification authorities.
Define safety requirements and safety integrity levels (SIL / ASIL / DAL) based on hazard analyses; translate safety requirements into actionable engineering requirements and verification activities.
Create, review and approve safety plans, safety concept documents, safety assessment reports, and safety compliance matrices for programs and product lines.
Establish and manage verification and validation strategies for safety functions, including test plans, test procedures, simulation, hardware-in-the-loop (HIL), and software verification to demonstrate mitigation effectiveness.
Support and lead certification and regulatory activities by preparing artifacts, responding to authority inquiries, coordinating audits, and liaising with certification bodies (FAA, EASA, TÜV, NHTSA, FDA, etc.).
Perform independent safety assurance assessments and audits of product design, development processes, supplier deliverables, and production changes to ensure continued compliance with safety requirements and standards.
Drive system-level hazard mitigation design, recommend architecture changes, redundancy strategies, fault detection and recovery mechanisms, and safe-state behavior.
Conduct root cause analysis and incident investigations following safety events, near-misses, field failures, and drive corrective and preventive actions (CAPA) with engineering teams and suppliers.
Maintain and enforce configuration management and traceability across requirements, design, verification evidence, and safety artifacts to support audits and certification.
Define and maintain safety-related processes, procedures and templates (safety management plan, hazard log, safety case structure) and ensure consistent application across programs.
Work closely with cross-functional teams (systems, software, hardware, test, manufacturing, operations) to integrate safety requirements and ensure safety-by-design principles are applied.
Evaluate supplier and third-party component safety data, perform supplier safety audits, and enforce supplier safety requirements and acceptance criteria.
Analyze field data and telemetry for trends, failure modes and to validate assumed risk models; update hazard logs and safety cases as field evidence emerges.
Provide technical subject-matter expertise on applicable industry standards and regulations such as ISO 26262, IEC 61508, DO-178C, DO-254, ARP4754A/ARP4761, MIL-STD-882, and ISO 14971, advising programs on interpretation and implementation.
Drive quantitative risk assessment (QRA) and probabilistic safety assessments (PSA) where applicable, and present risk estimates and residual risk to stakeholders and program leadership.
Mentor and coach engineers and stakeholders on safety engineering best practices, hazard analysis techniques, and safety lifecycle compliance.
Facilitate safety review boards, design reviews, and safety assessments; prepare and present safety review materials to program leadership and external auditors.
Support software and hardware integration activities with a safety focus, including safety-critical partitioning, verification of safety mechanisms, and assessment of COTS/legacy components for safety suitability.
Maintain a living hazard log and change-control process for safety-critical changes; assess safety impact of engineering changes and approve or reject changes based on safety analysis.
Prepare and negotiate safety requirements and acceptance criteria with customers, OEMs, and regulatory bodies; ensure contractually required safety deliverables are met.
Implement Safety Management System (SMS) practices and contribute to continuous improvement initiatives that reduce organizational safety risk.
Keep abreast of emerging safety standards, regulations, tools, and methods; recommend upgrades to processes or training to maintain compliance and technical excellence.
Support software tooling for safety engineering (requirements management, hazard tracking, verification traceability) and lead efforts to standardize tooling and automation to scale assurance activities.
Lead human factors and usability-oriented safety assessments where operator interaction influences safety outcomes; recommend mitigations such as alarms, interlocks, and procedures.
Coordinate cross-program safety harmonization activities to ensure consistency of safety approaches, common reuse of safety artifacts, and reuse of verified safety functions where appropriate.

Secondary Functions

Provide subject matter input to procurement and supplier selection with a safety perspective.
Support training programs, workshops, and internal certification for safety engineering practices.
Assist program managers in estimating safety assurance effort and creating safety-focused schedules and milestones.
Participate in post-market surveillance, maintenance planning, and end-of-life safety risk management.
Contribute to company-level risk registers and executive safety briefings.
Support business development and proposal efforts by drafting safety approach sections and expected compliance deliverables.
Participate in cross-functional incident response teams during safety-critical events.

Required Skills & Competencies

Hard Skills (Technical)

System Safety Engineering: expertise in conducting FHA, FTA, FMEA, STPA and maintaining hazard logs with end-to-end traceability.
Safety Case Development: experience building structured safety arguments and supporting evidence for certification and regulatory approval.
Standards & Regulations: demonstrated knowledge and application of industry standards (ISO 26262, IEC 61508, DO-178C, DO-254, ARP4754A/4761, MIL-STD-882, ISO 14971) and familiarity with certification processes.
Risk Assessment & Quantification: ability to perform qualitative and quantitative risk assessments, SIL/ASIL allocation, and probabilistic risk modeling.
Verification & Validation: strong background in verification planning and execution for safety functions, including test, simulation, and HIL strategies.
Requirements Management & Traceability: proficiency with tools and approaches to manage safety requirements and trace evidence (IBM DOORS, Jama, Polarion, JIRA, etc.).
Configuration & Change Management: understanding of CM processes to ensure safety artifacts remain consistent and auditable.
Software/Hardware Safety: experience assessing software and hardware components for safety (including COTS), partitioning, and failure mode considerations.
MBSE & Modeling: experience with model-based systems engineering (SysML) and safety modeling tools to represent architectures and failure propagation.
Data Analysis & Field Safety Monitoring: capability to analyze field performance, telemetry, and failure data to validate risk models and update safety cases.
Certification Liaison: experience interacting with certification authorities and preparing responses to audit findings and requests for information.
Human Factors Integration: knowledge of how human interaction affects safety and ability to recommend mitigations (UI/UX, procedures, alarms).
Formal Methods & Static Analysis (desirable): exposure to formal verification, static code analysis, or model checking methods in safety-critical software.
Tooling: familiarity with safety engineering and verification tools (requirements, test management, DO-178/ISO tool qualification considerations).

Soft Skills

Strong written and verbal communication skills for clear, concise safety argumentation and presentations to technical and non-technical stakeholders.
Leadership and influence: ability to lead cross-functional safety activities without direct line authority and drive decisions that balance safety, schedule, and cost.
Analytical thinking and problem solving, with attention to detail and the ability to synthesize complex information into actionable conclusions.
Project and time management to prioritize multiple safety deliverables and meet certification milestones.
Stakeholder management and negotiation skills for working with customers, suppliers, and regulators on safety requirements and evidence.
Coaching and mentoring to grow safety competence within engineering teams and foster a safety-first culture.
Adaptability and resilience when responding to evolving program needs, regulatory changes, and post-market issues.
Ethical judgment and impartiality when conducting independent safety assurance and assessments.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Engineering (Aerospace, Electrical, Mechanical, Systems, Computer), Computer Science, or related technical discipline.

Preferred Education:

Master's degree in Systems Engineering, Safety Engineering, Reliability Engineering, or a related advanced engineering degree.
Professional certifications such as Certified Functional Safety Expert (CFSE), TÜV Functional Safety Engineer, Certified Safety Professional (CSP), or equivalent are highly desirable.

Relevant Fields of Study:

Systems Engineering
Safety / Reliability Engineering
Aerospace, Automotive, Medical Device Engineering
Computer Science or Software Engineering (for software safety focus)

Experience Requirements

Typical Experience Range:

5–12+ years of progressively responsible experience in system/product safety engineering and assurance for regulated industries (aerospace, automotive, medical, defense, industrial).

Preferred:

8+ years with demonstrable experience leading safety cases and certification efforts.
Proven track record working with certification authorities (FAA, EASA, TÜV, FDA, NHTSA) or equivalent.
Prior experience with multidisciplinary engineering teams, supplier management, and post-market surveillance.
Demonstrated use of safety engineering tools and strong record of delivering safety-compliant products to market.