Job Description

You are responsible for:

·        Defining, for products to be developed, the applicable safety standards and regulations such as IEC 60601 series and/or IEC 62304, IEC 62366, the new EU MDR and Particular Standards IEC60601-2-43 and IEC60601-2-54

·        Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance.

·        The project deliverables related to Norm Compliance / Product Safety Certification responsibilities.

·        Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables

·        Supporting designers and testers with the interpretation and testing of standards and regulations with respect to the technical design of DXR products

·        Arranging and completing all evidence for gaining product certification by the independent certifying agency

·        Providing the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countries

·        Own norm compliance portfolio for DXR products and execute end to end activities in accordance with regulations.

·        Work on the project deliverables related to Norm Compliance release evidence – Generate Technical File for MDD & MDR certification.

·        Identification of relevant clauses from standards for (sub)system, Standards mainly includes IEC60601-1, IEC60601-2-43, IEC60601-2-54, etc.

·        Definition of product requirements to assure norm-compliance / Product Safety Certification.

·        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/TUV/FDA/BSI etc).

·        Test lab interaction experience.

·        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.

·        Contributing to Technology Roadmaps

·        Build norm compliance team and coach them on various activities with the portfolio

You are a part of

Philips Healthcare Innovation Center (HIC) Pune 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 head-quarters 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

·        BE/BTech/ME/MTech in bio-medical / Electronics engineering having 8+ years of experience with minimum 3 years of experience in the X-ray system/subsystem design & development (or at least two end to end X-ray product development) (or experience of medical products safety certification & regulatory approvals).

·        Knowledge of relevant regulations (UL, CSA, IEC, ISO, MDR (CE mark), etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.)

·        Knowledge on project organization, ISO 13485 and ISO 14971.

·        Knowledge of IEC 60601 standards, risk management, verification and validation of medical devices.

·        Knowhow of design control processes for medical device design.

·        Working knowledge of cabling design, design for EMI/EMC , Design for reliability.

Good team player and ability to work independently, act pro-actively, and drive for results.

·        Analytical, creative and abstract thinker.

·        Excellent communication skills - Ability to communicate (both written and verbal) on different levels.

·        Capable to introduce efficiency improvements on project level (change management).

·        System thinking mindset and domain expertise in the related area.

·        Fast learner and interest to learn new technologies/business/systems.

·        Be structured and self-organized.

Self-motivational, mindset to simplify and reach to solutions with speed.

·        Intercultural sensitivity.