Responsibilities: Expert in IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-2, ISO 14971 and experience with particular standards related to infusion pumps (IEC 60601-2-24). Expert in developing strategies according to business per applicable standards encompassing EMC and Safety. Expert in Electrical design review including deep understanding on layouts and schematics (EIT or PE preferred). Able to train cross functional staff on various standards and perform impact assessment on standard updates. Read, interpret and communicate changes in technical regulations, directives and standards. Review new and existing designs for compliance to the latest directives and standards. Oversee lab control and certifications. Lead Safety and EMC testing projects with test labs -some local travel required. During DCA, provide determination on what testing is needed with regards to Safety and EMC requirements. Coordinate any required changes with mechanical, electrical, and software engineers. Drive product certifications across development teams and testing labs. Compile data and write reports regarding existing formal testing done at an accredited lab. Prepare and/or edit test procedures to be used for EMC/Wireless formal evaluations. Facilitate safety reviews of products systems and/or components as part of new product development and modify / update existing products. Lead cross-functional teams to address product compliance related issues. Define and lead all aspects of the hardware certification test requirements and validate testing reports for accuracy, completeness, and ensure all mandatory requirements are properly accounted for in complete package. Stay current on relevant regulatory developments and new technologies. Ensure appropriate technical documentation exists for each project (e.g., design history files, risk analysis reports, software development records, etc.). Manage CAPA for product stewardship and electrical safety. Requirements: Bachelor's degree in engineering or related field from an accredited university or college. Minimum 8 years' experience working on medical device software and hardware development projects. Experience with ISO 14971, ISO 17025, IECEE procedures and audits, IEC 62304, Usability IEC 62368 Should be proficient in working with both IEC 62304 and IEC/EN 60601 for medical device manufacturing. Working knowledge of regulatory requirements such as FDA 510(k) submissions and EU MDR/IVDR. Strong understanding of development life cycle. Experience with working with test labs, NRTLs (i.e. TUV, CSA, UL, etc.), updating technical files, and obtaining agency approvals.). Attentiveness to details with strong organizational skills. Ability to work proactively and independently. Excellent communication skills, both written and verbal. Must be able to communicate technical information effectively to both technical and non-technical personnel. Travel Requirements: