Job Description:
Graduate electrical/electronics engineer with 10-12 years’ experience
Must have worked on projects involving all the phases of medical device development for USFDA and European norms
Lead the effort for system engineering projects involving requirement analysis, elaboration on system, subsystem and elements involving hardware, software, accessories etc.
Able to generate and review system engineering strategy including what, when, why, who and how a medical device verification and validation is achieved.
Working knowledge on wireless protocols such as Bluetooth, Wi-Fi is preferred
Propose changes as essential and ensure test plans and reports are aligned to organization standard operating procedures regulatory requirements, client’s policies, procedures, program schedule and budget
Propose design changes and construct in-house tests to verify the product design features related to functionality and compliance
Provided strategic communication with other product team on system engineering and work with cross functional team to achieve project deliverables within targeted timelines
Awareness on safety, EMC, environmental/climatic impact, vibrations and shock impact etc. standards on various regulatory and certifying institutions like CE, ATEX, SIL, UL, IEC, CSA, TUV etc.
Knowledge on risk and hazard analysis tools and techniques such as HAZID, FMEA, FMECA, HAZOP, SWIFT is plus
Scripting knowledge to automate testing is preferred but not mandatory
Experience(s), education and knowledge required:
Excellent communication skills and the ability to work with the business and all project team members
Strong sense of ownership, with a passion for delivery
Should be a self-starter person who takes initiative to solve problems
Knowledge of Mobile Application(Preferred)