Armin Wehrle - Head of Functional Safety & R&D Processes

Recommended expert

Erlangen, Germany

Experience

Jun 2023 - Jun 2024

1 year 1 month

Germany

Planning and coordinating all safety activities and organizational development to meet the requirements of ISO 26262 and IEC 61508
Process development according to Automotive SPICE™ and ISO 26262
Setting up and leading the CoC Functional Safety Management and coordinating and overseeing safety activities across all projects (ASIL C and ASIL D)
Stakeholder management and alignment with OEMs, DIA/RASIC coordination
Guiding team members on developing functional safety and relevant work products for safety validation
Planning, coordinating, monitoring and progress analysis of work package creation and action tracking
Planning and conducting safety assessments and audits for internal sub-projects and external suppliers
Developing the safety plan and supporting the creation of work packages for the safety case
Performing FMEAs, FMEDAs and FTAs
Coordinating, developing and conducting safety training
Resource and deployment planning, budget planning and controlling
Planning, tendering, contracting and coordinating temporary external support services
Interdisciplinary planning and coordinating activities in functional safety management according to ISO 26262
Conducting ASPICE™ maturity assessments and deriving process improvements based on standard requirements
Planning, coordinating and compiling the safety case
Central point of contact for functional safety across all organizational levels as well as NBs, OEMs and suppliers
Reporting to the division manager

Oct 2015 - Present

10 years 4 months

Temporary leadership of development departments as an interim manager for clients in an innovative high-tech environment
Consulting on implementing functional safety according to ISO 26262, IEC 61508, IEC 60601-1, ISO 14971, EN 50126/128/129
Supporting the establishment of a safety culture, creating safety plans, FMEAs, FMEDAs, FTAs, and safety case work products
Conducting internal safety audits and assessments
Optimizing the process landscape according to ISO 330xx and assessing based on ISO 33020 (SPICE/ASPICE™ 3.1/4.0)
Documenting existing process flows according to BPMN 2.0 and developing an optimization roadmap
Supporting ASPICE™ assessments as a co-assessor according to INTCAS® statutes
Advising MedTech companies on implementing/optimizing ISO 13485 certification and medical device approval (MDR/FDA/global)