Engineer
following: U.S., Canadian, and other International product safety standards, i.e., ANSI, CSA, UL, EN, IEC; Defining problems...
following: U.S., Canadian, and other International product safety standards, i.e., ANSI, CSA, UL, EN, IEC; Defining problems...
Level 3 and ISO 9001: 2015, ISO/IEC 20000-1:2011, ISO/IEC 27001:2013, ISO 14001 Certified Small Disadvantaged Woman Owned...
, resulting in CMMI Level 3 certification and ISO registrations including 9001:2015, 20000-1:2018, and ISO/IEC 27001:2013. SMS...
of US and international medical device regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, IEC 82304, AAMI TIR45, ISO 14971..., AAMI TIR57, IEC 60601 series, IEC 62366. Solid understanding of developmental best practices for medical device software...
plants Knowledge of pertinent regulatory, electrical, and safety standards from NRC, ANSI B11, NFPA, OSHA, IEC, ISO, WAC...
environment Additional Preferred Skills: * Familiarity with IEC 61131-3 standard Familiarity with Rockwell, Siemens... platforms of Legacy Embedded Systems Experience with ISO/IEC/IEEE Systems and Software Standards Additional Information...
and applicable standards, including but not limited to ISO 13485, ISO 14971, IEC 62304, FDA CFR 21 parts 803 - 820, EU MDR (2017/745...
device industry standards such as ISO 10993, ASTM F2992-18, IEC 60601-1-2, and UL 60601-1-2. Understanding of the...
Experience with designing for compliance to IEC 60601-1. RF Design/Testing experience. Medical device or biomedical device...
following: U.S., Canadian, and other International product safety standards, i.e., ANSI, CSA, UL, EN, IEC; Defining problems...