Enrich global experience within medical domain and build expertise in medical device electronics testing
Invasive and Non-Invasive Class II/III medical device electronics hardware Design History Files (DHFs) remediation
Design, develop and maintain hardware testing aspects for sleep and respiratory care products like Hospital/Home Ventilators
Identifying appropriate test technologies for overall system, sub-system and component levels.
Ensure test solutions are consistent with the higher-level architecture and requirements and complies with Global Regulatory and Safety requirements.
Play electronics test engineer subject matter expert role in the development of new concepts for ventilator products and systems
You are responsible for
Understand electronics subsystem requirements and review requirements from testability point of view.
Define electronics subsystem test plans, test strategies and test protocols
Analyze test protocols to ensure that test coverage of requirements is complete and correct
Write, update, and execute manual and automated test procedures
Work with cross functional teams to analyze test failures and determine root cause
Maintain tools and equipment used by the development and test teams
Coordinate the return of equipment to the calibration department for periodic maintenance
Review and assess the impact of equipment that fails calibration, and document calibration requirements for newly acquired equipment
Follow applicable Quality System procedures for all assigned tasks
Communicate ideas and issues effectively to other team members and management.
Prepare test documents, technical reports, presentations, as required.
Collaborate with cross-functional teams regarding standards compliance and global regulatory requirements (e.g., IEC 62304, ISO (International Standardization Organization) 14971, FDA (Food and Drug Administration (USA)) cGMP, QSR, ISO 13485, EU (European Union (formerly ECC or EC)) MDR (Medical Device Regulation)).
Support the manufacturing engineering team in troubleshooting and resolving issues discovered during production
To succeed in this role, you’ll need a customer-first attitude and the following
Minium B.E/B.Tech Electronics Engineering from reputed institute
3+ years of experience with electronics hardware testing and medical device test documentation.
Solid knowledge on electronic / electro-mechanical components
Knowledge of medical device regulations and standards (e.g., IEC 60601-1, EU-MDR, FDA cGMP).
Understanding of ventilator and gas sensing products, applications, and technologies a plus
A strong team player with good communication skills
Fluent in verbal and written English, proactive, can-do attitude, team player, decisive and entrepreneurial attitude
Display perseverance & agility with execution excellence mindset
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