Principal Functional Safety Engineer – Semiconductor, Automotive, ISO 26262 ASIL D / ASPICE 3
Ethernovia
Cyber Security
Staff Risk Management Engineer
Abbott
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $97,300 - $194,700 per year
Job Level
Lead
Tech Stack
Cyber Security
About the role
- Support/execute product/system risk management plan and planning
- Support requirements development to assure quality of requirements and linkage to risk management file
- Support System Hazard Analysis; support risk assessments (FTAs, FMEAs)
- Analyze and incorporate legacy inputs; coordinate/integrate cybersecurity risk with patient safety implications
- Maintain traceability among hazards, risks, risk analyses, evaluations and risk controls, and verify implementation and effectiveness of risk controls
- Support writing of system/product risk management reports
- Be point of contact for tracking and developing response to post market signals (event-based and periodic) and lead resulting risk management file updates including annual risk file updates
- Complaint analysis and related action planning/response
- Provide backroom support for audits
- Develop proficiencies in primary risk assessment tools (e.g., FMEA, FTA)
- Identify opportunities for improvement and drive/support process/infrastructure changes
- Support CAPA efforts with linkages to Risk Management Process or Execution
- Support all Company initiatives in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements
- Bachelor level degree in Engineering or Technical Field
- 8 + years’ experience
- Previous design quality engineering experience and demonstrated use of quality tools/methodologies
- Experience working in a broader enterprise/cross-division business unit model
- Preferred: Advanced Degree
- Preferred: Prior medical device experience
- Preferred: Working understanding of FDA, GMP, and ISO 13485
- Preferred: Working understanding of ISO14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993, and/or ISO 14155
- Preferred: Systems or clinical engineering experience
- Preferred: Experience with basic statistics and/or reliability methodologies
- Preferred: Experience facilitating risk assessments (e.g., FMEAs or FTAs)
