8 Dhf Jobs

Develops, establishes and maintains quality engineering methodologies, systems,practices which meet BSC,customer,regulatory requirements. Serves as a Quality representative to improve awareness,visibility,communication on quality initiatives Required Candidate profile Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.

Note: Qualification: B.Tech / B.E. in Biomedical Engineering, Biotechnology, or related Medical Engineering field (Pharma background (B. Pharma / M. Pharma) profiles will not be considered) Mandatory Skills: Regulatory Affairs Medical Devices EU MDR compliance Design History File (DHF) Risk Assessment & Risk Management Familiarity with ISO 13485 and other applicable standards Key Responsibilities: Prepare, review, and manage regulatory submissions for medical devices (India and international markets) Ensure compliance with EU MDR (Medical Device Regulation) and local regulatory requirements Maintain and update Design History Files (DHF) , Technical Files, and Risk Management documentation Conduct risk assessments and support implementation of risk mitigation strategies Work closely with cross-functional teams R&D, Quality Assurance, and Product Development to ensure regulatory compliance Monitor changes in medical device regulations and assess their impact on company products Interface with regulatory bodies for product approvals and audits

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 Files (DHF) and Risk Management Files (RMF). Conduct design verification and validation activities, ensuring product safety and efficacy. Develop and implement risk management activities including Failure Mode and Effects Analysis (FMEA). Collaborate with cross-functional teams to ensure effective design transfer from R&D to manufacturing. Support the creation and review of technical documentation, including design inputs/outputs, specifications, and reports. Manage non-conformances, CAPAs, and change management activities related to design quality. Provide guidance on regulatory requirements and standards related to orthopedic implant design. Participate in internal and external audits, including regulatory inspections.

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 towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional : Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology-CAD-CAD - Others

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 reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others

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 manufactured and verified. Lead or support design activities including design verification, validation, test procedure development, usability engineering, and risk management. Generate or apply statistical methods with appropriate risk-based justification. Hands-on experience in Design History File compilation / Technical file documentation. Support internal and external inspections/ regulatory audits. Promote continuous improvement in design control activities and use of quality tools with design team. In-depth knowledge and understanding of 21 CFR Part 820 Quality System Regulation, ISO 13485 Quality Standard, 21 CFR 4 Regulation of Combination Products, 14971 Risk Management Standard, MDD, MDR, IEC/EN 62366 Application of Usability Engineering to Medical Devices, and ANSI HE75 Human Factors Engineering in Design of Medical Devices Secondary responsibilities (Wherever applicable): Experience interacting with regulatory agencies and notified bodies Experience with process improvements, process qualification and validation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance.