EMC and Safety Engineer

Job Title: EMC and Safety Engineer (E&S)

Basic Job Purpose:

· The E&S Eng. works closely with external testing bodies and regulatory agencies, as well as with our internal R&D, RA and QA teams to ensure compliance of Sustain products with the applicable medical standards, while clearing compliance obstacles as early as possible.

· The E&S Eng. provides wide view of cross programs alignment to improve commonality, efficiency, and costs.

· To verify that our medical devices has developed & manufactured according to the regulatory standards requirements.

· To be focal point (SME) for SII & External labs collaboration.

Main Duties:

· Safety & EMI Compliance Gatekeeper for Laser Franchise Products throughout development & Sustain phase.

· Coordinate and monitor product Submissions and Testing at SII and external Labs.

· Maintain EMC & Safety Records and update records per procedure/project.

· Investigate root cause of EMI/RFI & Safety issues and suggest actions and solutions.

· Provides status reports concerning all Safety & EMC activities.

· Collaborate with R&D / Engineering in Design review of the device to achieve robust level of safety & EMC

· Collaborate with V&V Team during sustain phase of the product.

· Attending meetings, writing Protocols & Reports and communicate presentations to managers and clients.

· Attending audits and meetings with subcontractors in and out of the country.

· Keep updating and learning new regulations.

Required Qualifications:

· B.Sc. in Electrical Engineering from a well-known institute - Must

· 2+ years of experience in multi-disciplinary medical device company - Must

· Proven work with EMC & Safety of Medial regulatory standards and certification requirements (e.g. UL, CSA, IEC, particular IEC60601-1, IEC60601-1-2).

· Ability to read and interpret regulatory standards and to consolidate requirements for technical audiences.

· Experience with laboratory instrumentation, Hands-On (analog/digital meters, oscilloscopes, data acquisition systems, etc.)

· Electrical Troubleshooting problem-solving skills & design for EMI & Safety.

· Ability to develop and , departmental work procedures.

· Systemic & Process point-of-view Skills.

· Strong attention to detailed and high accuracy capabilities.

· Excellent communication in Hebrew and English (verbally and written).

· Good organizational and Leading skills.

· Basic Microsoft Office proficiency

· Driving License