Armin Wehrle-Head of Functional Safety & R&D Processes
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Experience
Head of Functional Safety & R&D Processes
SEMIKRON Danfoss GmbH & Co KG
- 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
Management Consultant
Self-employed
- 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)
Industry Experience
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Experienced in Automotive and Healthcare.
Business Area Experience
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Experienced in Product Development, Quality Assurance, Strategy, and Project Management.
Languages
Education
Diploma Engineer (FH) in Electrical Engineering / Communications Engineering · Electrical Engineering / Communications Engineering
Certifications & licenses
Certified Automotive Functional Safety Professional
TÜV/SGS Saar
intacs® Certified Provisional Assessor (Automotive SPICE™)
intacs®
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
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Professionals working in or nearby Erlangen, Germany
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