Hamid Omidi Email & Phone Number

United States

Watertown, Massachusetts, Us

Minneapolis, Mn, Us

Medtronic, CVG. Danvers MA Sr. Manufacturing Engineer, CVG Products. Design manufacturing processes, procedures, and production layouts for assemblies. • Created SOPs and procedures for the fabrication of tools. • Incorporated inspection and test requirements into the production plan. • Inspected performance of machinery, equipment, and tools to verify their efficiency. • Investigated corrective action of problems and deficiencies to ensure product quality. • Developed manufacturing processes that apply to statistical process control. • Provided engineering support for design concepts and specification for manufacturing techniques. • Ensured processes and procedures follow FDA and EU regulations.• Generated ECOs and NCRs as well as maintenance schedules.• Authored documentations for IQ, OQ, PQ validations in accordance to QSR, FDA and EU.• Originated ECN in compliance with quality systems Regulation (QSR21 CFR820, ISO 13485.• Mentored Technicians on Laboratory/ Quality Process Testing and Validation.• Conducted daily tasks and objectives with colleagues in cross functional projects.• Performed risk assessment and Gap analysis activities to identify product quality and/or compliance risk and lead efforts to mitigate the risks including PFMEA updates.• Maintained a MES (ORBIS) system support to integrates process knowledge, equipment design, and quality standards.