8 13485 Jobs

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. ...

OPENING FOR A WELL KNOWN OIL AND GAS COMPANY In MIDDLE EAST: Position: Medical Devices-Assessor/ Auditor Experience: Require about 10 years of professional experience in relevant field of healthcare products or related activities e.g.: work in medical devices industry such as research and development, manufacturing, quality management, regulatory affairs. 5 + years relevant professional experience in quality management is essential. Minimum Requirement: Good knowledge of ISO 13485, MDD 93/42/EEC/ Indian Medical Device Regulations and their application & Knowledge of MDR 2017/745, MDSAP, IMDR Experience with Risk Management EN ISO 14971 Solid knowledge of non-active devices & Solid knowledge ...

Role/Summary: Collaborate with cross-functional teams to identify and assess risks associated with medical device development and integrate risk management activities into the V&V process, ensuring that potential hazards and risks are adequately addressed and mitigated in accordance with ISO 14971. Utilize risk-based testing methodologies to prioritize V&V activities based on the level of risk associated with medical devices. Evaluate the effectiveness of risk controls and mitigation strategies through V&V testing activities. Develop verification and validation protocols and test plans based on product requirements, design specifications, and regulatory standards. Document and maintain compr...

The Program Manager will be a senior program leader in the PCS (Patient Care Solutions) NPI excellence team in driving initiatives to improve the effectiveness of the NPI excellence and operations functions and interfaces with other functions to provide effective coordination of metrics, dashboards, functional processes, and cross-functional initiative coordination • Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. • The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.) • Should have 12+ ye...

### Job Title: Development Engineer Plastic Injection Molding Medical Devices ### Company Overview: InnoIQ Engineering a Subsidiary of B&W Engineering und Datensysteme GmbH Germany is a leading company specializing in the research, design, and development of innovative medical devices. With a focus on precision, quality, and customer-centric solutions, we partner with global clients to bring advanced medical technologies to life. Our expertise extends from concept design and prototyping to production support, offering comprehensive engineering solutions for the medical device industry. For more details about our services and company profile, please visit www.innoiq.in Job Title: Development ...

Electronics Engineer Medical Device Product Development Location: Pune, Maharashtra, India Employment Type: Full-Time Experience Required: 57 years About InnoIQ Engineering InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH (Germany), excels in research, design, and development of precision medical devices. From concept through regulatory compliance and production support, we deliver innovative, high-quality solutions for global clients in the medical device space. Role Overview As a key member of our team, youll lead electronics design for new medical devicesfrom schematic capture and PCB layout using Altium Designer , to component selection and prototype validation. ...

Engineering degree with minimum 5-10 years experience in LMS & QMS Administration of Quality Management Systems Experience with a learning management system Experience in developing and facilitating training Experience using SharePoint

Bachelors degree in Engineering 8+ years of quality systems experience Experience in Process Development, Validation& MSA, is Mandatory Working knowledge of auditing experience to the FDA Quality System Regulation, ISO 13485, and the MDD