Compliance Engineer

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality that utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death.

Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.

Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer, and other types of solid cancers. 

We are looking for a Compliance Engineer who will join the Product Development department and participate as a project team member for a variety of projects, including new designs, design changes, and submissions in new markets.
 

The Compliance Engineer will define design inputs for complying with relevant safety, EMC, and other relevant environmental standards, will participate in design reviews to ensure inputs are addressed, will maintain communication with the relevant laboratories, lead the actual safety and EMC compliance testing process, and will review and approve the safety and EMC reports for correctness and accuracy.
 

The Compliance Engineer will also communicate with the certification laboratories for clarifications and required modifications for safety and EMC reports.

A good candidate will have to present a strong knowledge of medical safety and EMC standards, how to generate design inputs for complying with them, and how tests are conducted and executed.

This is a full-time position, reporting to the senior manager, Engineering, and will be based in Haifa, Israel. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Work closely with external testing laboratories, compliance agencies, and regulatory bodies, as well as with our internal  PD, RA, and QA teams to ensure compliance of new and sustainable products with the applicable medical standards, while clearing compliance obstacles as early as possible.
• Define relevant standards per product specifications or RA requirements
• Provide design inputs to comply with Safety & EMC medical standards.
• Verifying that Novocure products are developed & manufactured according to the state-of-the-art regulatory standards requirements.
• Act as a focal point (SME) for certification labs.
• Coordinating and monitoring product submissions and testing at certification labs.
• Maintaining EMC & Safety Records and updating records as required.
• Investigating root cause of EMI/RFI & Safety issues and suggesting actions and solutions.
• Providing status reports concerning all Safety & EMC activities.
• Collaborating with Engineering in design reviews of new and revised products to achieve a robust level of safety & EMC
• Collaborating with the V&V Team during the verification phases of new and revised designs.
• Attending meetings, review and approve safety and EMC reports
• Keep updating and learning new regulations.

QUALIFICATIONS/KNOWLEDGE:

• Qualifications:
• B.Sc. in Electrical Engineering – mandatory
• M.SC in Electrical, System, or other relevant engineering discipline is an advantage

• Knowledge:
• 5+ years of experience in a multi-disciplinary medical/military industry company - an advantage for medical
• Proven work with EMC & Safety of Medial and/or military regulatory standards and certification requirements (e.g. UL, CSA, IEC, particularly IEC60601-1, IEC60601-1-2- an advantage)
• Ability to read and interpret regulatory standards and consolidate requirements for technical audiences.
• Experience with laboratory instrumentation, Hands-On (analog/digital meters, oscilloscopes, spectrum analyzer, data acquisition systems, etc.)
• Electrical Troubleshooting problem-solving skills & design for EMI & Safety.
• Systemic & Process point-of-view Skills.
• Strong attention to detail and high accuracy capabilities.
• Excellent communication in Hebrew and English (verbally and written).
• Basic Microsoft Office proficiency

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy

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