Boston Scientific EMC Safety Engineer 

Israel, North District, Yokneam Ilit 

490968332

Job Purpose:

• The EMC & Safety Engineer working 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.
• Providing wide view of cross programs alignment to improve commonality, efficiency, and costs.
• Verifying that Lumenis medical devices has developed & manufactured according to the regulatory standards requirements.
• Acting as a focal point (SME) for SII & External labs collaboration.

Main Duties:

• Safety & EMI Compliance Gatekeeper for Laser Franchise Products throughout development & Sustain phase.
• Coordinating and monitoring product Submissions and Testing at SII and external Labs.
• Maintaining EMC & Safety Records and update records per procedure/project.
• Investigating root cause of EMI/RFI & Safety issues and suggesting actions and solutions.
• Providing status reports concerning all Safety & EMC activities.
• Collaborating with R&D / Engineering in Design review of the device to achieve robust level of safety & EMC
• Collaborating 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 leading institute - mandatory
• 2+ years of experience in multi-disciplinary medical device company - mandatory
• 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 document, 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