35 Dhf Jobs - Page 2

Purpose of the role: The Design Quality Engineer will be responsible for ensuring the design, development, and manufacturing processes comply with regulatory requirements, industry standards, and company quality policies. This role will involve close collaboration with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality Assurance. Roles & Responsibilities: Ensure design control activities comply with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and standards (e.g., ISO 14971, IEC 62366). Participate in design reviews and provide quality engineering support throughout the product development lifecycle. Establish and maintain Design History Fil...

Join our Sustaining Project Team as a Design Quality Engineer. Handle DHF, risk management, V&V, doc control, and ensure compliance with quality systems & regulatory standards. Experience with PLCP, FMEA, and CAPA is preferred. Required Candidate profile This role is strictly focused on Design Quality Engineering. It does not include Regulatory Affairs or Post-Market Surveillance (PMS) responsibilities.

Educational Bachelor of Engineering,BTech,Master Of Engineering,MTech Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams tow...

Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan re...

Role & responsibilities: Product development experience in range of 4-7 years Experience with Medical device preferred. Experience with design change management and DHF deliverables. Good at communication Basic understanding of PLM/Windchill Technical report writing and communication with stakeholders. Skill Set: Must have - Product development experience Strong DHF Process Knowledege & working experience, ECN / ECR activities Techanical Report writing Medical Regulatory Medical domain Quality process Key Words & Tools: Medical Device design and development , Medical Domain Process, DHF , Risk Management , PLM activities Solidwork , PLM Windchill,

Verification and Validation R&D Primary responsibilities: Represent the Design Quality function on device development project teams and cross functional co-ordination with multiple departments including R&D, Quality Control, Manufacturing and Regulatory Affairs. Ensure that device development projects and changes to existing devices are conducted in compliance with the FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, and other applicable standards like ISO 14971. Provide input to design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately man...

Key Responsibilities: Create and update 2D and 3D CAD models and engineering drawings using SolidWorks. Maintain accurate CAD databases and revision-controlled design files in accordance with Quality Management System (QMS) protocols. Generate and maintain Bill of Materials (BOMs) for all products and design configurations. Support the Design History File (DHF) compilation by providing up-to-date drawings, BOMs, and release records. Ensure proper version control, file storage, and change documentation in alignment with document control procedures. Process Engineering Change Requests (ECRs) and execute Engineering Change Orders (ECOs) with appropriate drawing updates. Participate in design re...

Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions. Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485. Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files. Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating ...

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and r...

Packaging Validation Engineer: Lead and execute packaging validation activities with a primary focus on seal integrity testing for sterile barrier systems. Develop and implement packaging test protocols and reports in alignment with ISTA (International Safe Transit Association) and ASTM standards. Design and perform package performance and distribution testing, including drop, vibration, and compression tests. Collaborate with R&D, Quality, Regulatory, and Manufacturing to ensure robust package designs and validation strategies. Drive root cause analysis and CAPA related to packaging failures. Maintain compliance with applicable regulatory standards including ISO 11607, FDA 21 CFR 820, and r...