Norm Compliance Officer
2d ago

Job Description In this role, you have the opportunity to design, develop and maintain Diagnostic X-ray systems (Radiography, Fluoro & Mammography) and realization of a range of products in such a way that future products options and features can be realized with acceptable effects for the earlier products.

You are responsible for planning and tracking of electrical design, ensures risks are mitigated and communicated to stakeholders.

You will ensure that your design is consistent with the higher-level architecture and requirements. You are responsible for Work on the project deliverables related to Norm Compliance release evidence Generate Technical File for MDD & MRDR certification.

Identification of relevant clauses from standards for (sub)system, Standards mainly includes IEC60601-1, IEC60601-1-2, IEC60601-1-3 etc.

Definition of product requirements to assure norm-compliance. Decomposition towards the individual (sub)system elements.

Secure the implementation and verification of all specified legal requirements. Support with respect to technical realization / engineering of norm compliance of the (sub) system.

Support the verification (testing, witnessing and reporting and approval) of all specified legal requirements. Be the intermediary between development and certifying / regulatory agencies (UL / CSA / FDA / BSI etc).

Support arrangements for and completion of submission to certifying agencies. Review standard updates and deploy revised standards.

Identification of approbation consequences due to change requests. (Notified Body Audits) Train and inculcate design and cross functional teams on regulatory standards, update and execution.

You will be part of Philips Healthcare Innovation Center (HIC) Pune. This is a product innovation center for multiple businesses with presence of R&D, Marketing, Customer Service, Procurement, Quality and Manufacturing functions.

The center is focused on developing smart and reliable X-ray imaging based Diagnostics and Treatment products with enhanced patient safety to meet the unmet needs of a wide range of global hospital customer base.

HIC Pune is the global headquarters for the IGT Mobile Surgery business and it has a significant R&D presence for the Precision Diagnosis Cluster.

In recent years, HIC Pune has become the hub for the growth of Diagnostic X-Ray, CT / AMI, MR and Imaging Components businesses.

To succeed in this role, you should have the following skills and experience M.Tech / ME in bio-medical engineering having IQ specialization with 5 -9 years of experience.

In depth understanding of system wide IQ, combining IQ related theory (e.g. x-ray physics, image processing, visual perception, etc.

with understanding of relevant products and the application by the end-user. Good team player and ability to work independently & act pro-actively.

Analytical, creative and abstract thinker. Ability to communicate (both written and verbal) on different levels. Is capable to introduce efficiency improvements on project level (change management).

Good team player and ability to work independently & act pro-actively. Analytical, creative and abstract thinker. Fast learner and interest to learn new technologies / business / systems Why should you join Philips?

Working at Philips is more than a job. It is a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum.

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