Boston Scientific EMC & Safety Team Leader 

Israel, North District 

770341788

As the EMC & Safety Team Leader, you will ensure compliance with medical standards and address compliance obstacles early. You will coordinate with external notify bodies and internal teams to align programs, enhance efficiency, and plan the overall site compliance to relevant standards. You will verify that medical devices are developed and manufactured according to regulatory standards and act as the subject matter expert for collaborations with SII and external labs.

Main Duties:

• Responsible for EMC and Safety activities at the site.

• Responsible for Compliance to state of the art standards
• Manage Sustain and NPD safety and EMC engineers
• Manage subject matter experts for each standard
• Maintain PSL (Product Standard list ) evidence in Atlas
• Maintain compliance for other standards (RoHS, Usability, Environmental etc.)
• Identify noncompliance, lead the technical aspects of EMC /Safety risk assessment and close gaps
• Plan and Maintain compliance with standards updates
• Support Audits (NPD & Sustain) focusing EMC/Safety topics
• 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 communicating presentations to managers and clients.
• Attending audits and meetings with subcontractors in Israel and abroad
• Keep updating and learning new regulations.

Required Qualifications:

• B.Sc. in Electrical Engineering - mandatory
• 7+ years of experience in multi-disciplinary Medical Device company - mandatory
• Proven work with EMC & Safety of Medical regulatory standards and certification requirements (e.g. UL, CSA, IEC, particular IEC60601-1, IEC60601-1-2 ,IEC60601-22)
• 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.
• Highly Methodical and organized
• Basic Microsoft Office proficiency
• Driving License