Respironics Inc
Location
Pune | India
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 .
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