EMC & Safety Team Leader

יקנעם
משרה קבועה
משרה מלאה

לפני חודש

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.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

Requisition ID: 610207As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Boston Scientific

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