• NPSW SME for Abbott Kjelsas, Oslo site. Responsible for software and spreadsheet validation and verification according to SLC & SLP (cybersecurity) procedures.• Medical product development & electronics, skills include ISO standards for medical devices ISO 13485, IEC 60601 and risk management ISO 14971. Development experience of Class III medical diagnostic device. QMS documentation proficient and regulatory proficient FDA and MDR.• Managing experience of deviations, complaints, corrective & preventative actions (CAPA). Quality audits and reviews. Ability to Create modifies, review and complete Standard Operating Procedures (SOPs), validation and verification documents. UDI/labeling product and packaging experience according to MDR and FDA regulations. Knowledge of CGMP 21 CFR 820.• Strong initiative, problem-solving and collaborative skills resulting in $350,000 Grants. A Knowledgeable innovator with development, project, and data management experience resulting in 24 collaborative publications.• 8 years of experience in design analysis and mathematical modeling. I can conduct a mixture of applied and strategic research, develop high-quality simulations, publish papers and give presentations at international conferences. I have experience in instrumentation, measurement, and maintenance of electronics systems. • I have experience in MATLAB, LabView and programming language C. Strong expertise in computational design and analysis software COMSOL, and CoventorWare on mechanical, thermal, electrothermal and heat flow simulations. Project management skills with budgeting, scheduling, maintenance, procurement, and repair of equipment.Contact : umermian@gmail.com