Systems Engineer - Verification & Validation

The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations.

Your role:

• Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations.
• Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual system or sub-systems.
• Preparation of norm compliance test plan that include applicable relevant clauses from standards (standards mainly include IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-2-54, ISO 10993 etc.).
• Support in risk assessment related to product safety for achieving mitigation.
• Support usability and software teams to deliver documentation required for certification
• Support design and procurement team to ensure third party component level compliance
• Execute testing (witnessing, reporting and approval) of all specified product safety requirements.
• Arrangements of DXR product and required documents to test/certification agencies (like TUV/CSA/Any other lab) as part of submission and completion of certification activities.
• Support in preparing technical file deliverables (like GSPR and Compliance Data Record) in support to MDD, MDR, RED, REACH, RoHS regulations.
• Achieve certification of DXR products with all relevant global standards and regulations.
• Ensure timely delivery of all approbation activities / documentation adhering to Philips processes.
• Support the Regulatory team to achieve all regulatory approvals.
• Support all audits (FDA, Notified Body, INMETRO, etc).
• Review standard updates and provide standards gap assessment / technical support to the Regulatory team.
• Provide Training and guide all cross-functional teams on regulatory standards, update and execution.
• Maintain DXR compliance lab and its qualifications with CSA & Intertek as per ISO17025.
• Identification of approbation consequences due to change requests.
• Support factory inspections by certification agencies and address all audit observations in a timely manner (if applicable).
• Keep abreast of future upcoming regulatory & standards by interacting with notified body and standard organizations.

Preferred candidate profile

• BE, BTech, ME, MTech degree (preferably in Biomedical/ Electrical/ Electronics/ Instrumentation).
• Minimum 10 to 15 years experience in product safety.
• Understanding of global mandatory / voluntary regulations like CE Marking, FDA, Health Canada, UL, CSA, INMETRO.
• Understanding of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, ISO17025, etc.).
• Knows how to participate in Design Reviews from norm compliance perspective
• Knowledge of regulatory submissions.
• Knowledge of X-ray systems will be an added advantage.
• Prior experience in product design will be preferrable.
• Excellent Communication skills.
• Understanding and implementation of good document practice (GDP).
• Strong hold on Compliance standards.
• Knowledge of Product safety and regulatory.