4 Dhf Jobs

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.

Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer 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 Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

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,

Creation/modification of process flows within the Manufacturing/Service Departments. Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. Perform gap assessment and conduct remediation of documents with stakeholder inputs. Development and maintenance Manufacturing/Service Work Instructions and related documents. Creation/modification of fixtures, tooling, equipment and systems to support operations. IQ, OQ, and PQ of fixtures, tooling, and equipment. Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred. Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment. Experience with statistical software packages (Minitab is a plus), SAP, windchill, onePLM etc. Experience with Quality Systems and process controls in the medical device industry is desirable. Knowledge and working application of FDA, cGMP, ANSI/ISO/ASQC requirements. Knowledge and working application of technical part drawings and GD&T principles. Demonstrated application of engineering principles on individual/small projects and ability to work with cross functional teams to successfully implement quality improvement and cost reduction initiatives. Demonstrated strong analytical problem solving Root Cause Investigations, CAPA, Six Sigma, continuous improvement projects. Ability to multi-task and methodically lead/manage projects. Location: Chennai Required Skillset: Gap Assessment and Remediation for DMR, Class 2 and 3 device