Iec 60601 Jobs – Apply to Latest Iec 60601 Job Vacancies

Process and Documentation Engineer Xcellance Medical Technologies Pvt Ltd

3.0 - 7.0 years

3 - 4 Lacs

Navi Mumbai

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Role & responsibilities: Process Development &Optimization Define, document, and improve engineering workflows, protocols, and D&D procedures. Collaborate with cross-functional teams (Design, QA/RA, Manufacturing, Supply Chain) to standardize and streamline development processes. Support Design Control processes including Design Inputs/Outputs, Verification, and Validation activities. Technical Documentation Management Create, maintain, and control engineering documentation such as: Design History Files (DHF) Device Master Records (DMR) Engineering Change Orders (ECO) Risk Management Files (ISO 14971) Ensure traceability and version control using QMS tools. Assist in the preparation and formatting of documents for regulatory submissions (FDA, EU MDR). Compliance & Quality Support Ensure documentation and processes meet applicable standards: ISO 13485, 21 CFR Part 820, IEC 60601, and other regulatory requirements. Support internal and external audits by providing required documentation and process maps. Knowledge Transfer & Team Support Maintain structured repositories of technical documentation and templates. Train engineers and D&D staff on documentation best practices, process adherence, and use of documentation tools. Tools & Systems Use and help maintain Product Lifecycle Management and Quality Management Systems (QMS). Work with tools such as SolidWorks PDM, Windchill, Arena, or equivalent for document and change control. Preferred candidate profile

Posted 2 weeks ago

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Test Manager Products (Product Developer) Authentic Staffing Agency

9 - 14 years

10 - 20 Lacs

Vadodara

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Extensive Testing Experience: At least 10 years of experience in electronic testing, with a minimum of 2-3 years in a managerial role. In-depth knowledge of testing methodologies, tools, and techniques.

Posted 3 months ago

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Sr. system engineering Capgemini

4 - 7 years

3 - 8 Lacs

Ahmedabad

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Role & responsibilities 'Total 4-7 years of hands on system engineering experience involving electrical, mechanical, firmware out of which at least 3 years for medical devices is compulsory Proficient in product architecture design, define system interface & system verification strategy Proficient in products requirements capturing/ understanding. Proficient in product compliance testing involving mechanical, safety, EMC & environmental tests Good understanding of product reliability and functional safety Familiarity with the Design Controls in Medical Devices Experience in performing Risk Assessment & Control of the Electro-Mechanical Devices Experience in DFMEA, PFMEA, UFMEA and Software Risk Assessment Ability to review/ guide team on verification protocol for electro-mechanical medical device and define acceptance criteria Experience in prototype Manufacturing (Vendor Co-ordination, manufacturing, etc.) Understanding of handling of complete product traceability Experience working with standards such as ISO 13485, ISO 14971, IEC 60601, ISO 10993

Posted 3 months ago

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